CLASS II ONGOING Device recall · Reported 19 Nov 2025 · FDA Enforcement Report

Ceiling Type X-Ray Tube Support recalled by Shimadzu Corporation Medical

Shimadzu Corporation Medical Systems Division is recalling Ceiling Type X-Ray Tube Support, distributed nationwide in the US. The recall was initiated on 16 Oct 2025 and the FDA has classified it as Class II.

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Lot, batch or date codesModel Numbers: CH-200. UDI code: 04540217014484. Serial Numbers: 3ZC5C2A84014, 3ZC5C2A85003, 3ZC5C2A77013, 3ZC5C2A86013, 3ZC5C2A75012, 3ZC5C2A76002, 3ZC5C2A76016, 3ZC5C2A76026, 3ZC5C2A79003, 3ZC5C2A84008, 3ZC5C2A73001, 3ZC5C2A87008, 3ZC5C2A7A001, 3ZC5C2A76018, 3ZC5C2A79001, 3ZC5C2A7A002, 3ZC5C2A7B001, 3ZC5C2A85015, 3ZC5C2A81001, 3ZC5C2A86003, 3ZC5C2A7C007, 3ZC5C2A84002, 3ZC5C2A7B019, 3ZC5C2A77010, 3ZC5C2A73006, 3ZC5C2A74004, 3ZC5C2A75002, 3ZC5C2A75005, 3ZC5C2A75006, 3ZC5C2A75007, 3ZC5C2A76010, 3ZC5C2A76013, 3ZC5C2A76022, 3ZC5C2A77011, 3ZC5C2A77012, 3ZC5C2A77014, 3ZC5C2A77023, 3ZC5C2A78002, 3ZC5C2A78003, 3ZC5C2A79002, 3ZC5C2A7C006, 3ZC5C2A7C016, 3ZC5C2A82004, 3ZC5C2A83002, 3ZC5C2A85010, 3ZC5C2A85016, 3ZC5C2A85018, 3ZC5C2A86002, 3ZC5C2A86009, 3ZC5C2A86011, 3ZC5C2A87010, 3ZC5C2A88003, 3ZC5C2A88005, 3ZC5C2A81002, 3ZC5C2A85017, 3ZC5C2A7B002, 3ZC5C2A86004, 3ZC5C2A85005, 3ZC5C2A71003, 3ZC5C2A86010, 3ZC5C2A81004, 3ZC5C2A73012, 3ZC5C2A73013, 3ZC5C2A73014, 3ZC5C2A76006, 3ZC5C2A76019, 3ZC5C2A76027, 3ZC5C2A77003, 3ZC5C2A7B015, 3ZC5C2A85019, 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0262M44301, 0262M44302, 0262M44303, 0262M44408, 0362M40801, 0362M40802, 0362M40803, 0362M41407, 0362M41409, 0362M42404, 0462M40103, 0462M41202, 0562M42806, 0662M40808, 3ZC5C160C006, 3ZC5C1612002, 3ZC5C1613002, 3ZC5C1615001, 3ZC5C161B003, 3ZC5C1623002, 3ZC5C1631002, 3ZC5C1643002, 3ZC5C1643003, 3ZC5C1643005, 41E733E63001, 41E733E67001, 41E733E67005, 41E733E6B001, 41E733E6B009, 0462M40102, 3ZC5C160C004, 41E733E67004, 3ZC5C1645004, 3ZC5C162A002, 0462M41201, 3ZC5C1616004, 3ZC5C162B001, 3ZC5C1636001, 3ZC5C160C003, 0662M40809, 3ZC5C1616001, 3ZC5C1654001, 0462M41602, 3ZC5C1629005, 3ZC5C161A001, 0462M40202, 3ZC5C162A004, 0362M40510, 0462M44204, 3ZC5C1646002, 0162M43015, 0162M43016, 0162M43218, 0162M43614, 0262M40507, 0262M40710, 0262M42604, 0362M42405, 0562M43906, 3ZC5C164C002, 0362M43603, 3ZC5C1612004, 41E733E69005, 3ZC5C161A002, 3ZC5C1635001, 3ZC5C1629003, 3ZC5C1623003, 3ZC5C1629001, 3ZC5C1616003, 0462M42002, 3ZC5C1632002, 0162M43017, 0162M43612, 0262M40508, 0262M40607, 0262M43602, 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0262M42709, 0262M44304, 0262M44204, 0362M44905, 3ZC5C1612007, 3ZC5C1655001, 3ZC5C1661002, 41E733E69004, 0462M43401, 0462M43406, 0462M42104, 0462M43405, 0462M44002, 0462M45004, 0462M43201, 0162M43518, 0162M44510, 0262M43905, 3ZC5C1633002, 0362M41101, 0362M42303, 0362M42403, 0362M43604, 0362M44103, 3ZC5C1636002, 3ZC5C1629002, 3ZC5C1643004, 3ZC5C1613001, 0462M43803, 0462M44205, 0562M41105, 0662M40601, 3ZC5C1612001, 3ZC5C1623001, 0562M42803, 41E733E63004, 41E733E69001, 3ZC5C163A001, 3ZC5C1645003, 3ZC5C1648002, 0462M42105, 41E733E67003, 0462M41205, 3ZC5C1717001, 3ZC5C1628001, 41E733E6B006, 0262M44203, 0262M44807, 41E733E6B005, 41E733E6B007, 41E733E6B008.

Quantity recalled1,766 devices

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0499-2026
FDA event ID: 97365
Recalling firm: Shimadzu Corporation Medical Systems Division, Kyoto
Classification: Class II
Status: Ongoing
Recall initiated: 16 Oct 2025
FDA classified: 13 Nov 2025
Reported: 19 Nov 2025
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Device Malfunction
Device type: Imaging Equipment

Timeline

16 Oct 2025	Recall initiated by company
13 Nov 2025	Classified by FDA	+28 days
19 Nov 2025	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Due to an issue (potential breakage) with the shaft for the mounting of the X-ray tube assembly that could potentially result assembly coming off the rotating shaft.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Ceiling Type X-Ray Tube Support Models CH-200 and CH-200M used with RADspeed, SonialVision and FLUOROspeed Systems The ceiling type x-ray tube support CH-200 is used to hold the X-ray tube and collimator to position the X-ray tube unit. This unit is used for radiographic examinations of whole body except mammography when combined with an X-ray high voltage generator, an X-ray tube unit, an X-ray collimator, and if necessary, an X-ray radiography stand, an X-ray radiography table, and digital radiography system.

Where it was distributed

Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SM, SC, SD, TN, TX, VA, WA, and WI. The countries of Dominica, Grand Bahama, Haiti, and Saint Maarten.

Nationwide Alaska Alabama Arkansas Arizona California Colorado Connecticut Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland

Questions about this recall

Why was it recalled?

Due to an issue (potential breakage) with the shaft for the mounting of the X-ray tube assembly that could potentially result assembly coming off the rotating shaft.

Which lots are affected?

Model Numbers: CH-200. UDI code: 04540217014484. Serial Numbers: 3ZC5C2A84014, 3ZC5C2A85003, 3ZC5C2A77013, 3ZC5C2A86013, 3ZC5C2A75012, 3ZC5C2A76002, 3ZC5C2A76016, 3ZC5C2A76026, 3ZC5C2A79003, 3ZC5C2A84008, 3ZC5C2A73001, 3ZC5C2A87008, 3ZC5C2A7A001, 3ZC5C2A76018, 3ZC5C2A79001, 3ZC5C2A7A002, 3ZC5C2A7B001, 3ZC5C2A85015, 3ZC5C2A81001, 3ZC5C2A86003, 3ZC5C2A7C007, 3ZC5C2A84002, 3ZC5C2A7B019, 3ZC5C2A77010, 3ZC5C2A73006, 3ZC5C2A74004, 3ZC5C2A75002, 3ZC5C2A75005, 3ZC5C2A75006, 3ZC5C2A75007, 3ZC5C2A76010, 3ZC5C2A76013, 3ZC5C2A76022, 3ZC5C2A77011, 3ZC5C2A77012, 3ZC5C2A77014, 3ZC5C2A77023, 3ZC5C2A78002, 3ZC5C2A78003, 3ZC5C2A79002, 3ZC5C2A7C006, 3ZC5C2A7C016, 3ZC5C2A82004, 3ZC5C2A83002, 3ZC5C2A85010, 3ZC5C2A85016, 3ZC5C2A85018, 3ZC5C2A86002, 3ZC5C2A86009, 3ZC5C2A86011, 3ZC5C2A87010, 3ZC5C2A88003, 3ZC5C2A88005, 3ZC5C2A81002, 3ZC5C2A85017, 3ZC5C2A7B002, 3ZC5C2A86004, 3ZC5C2A85005, 3ZC5C2A71003, 3ZC5C2A86010, 3ZC5C2A81004, 3ZC5C2A73012, 3ZC5C2A73013, 3ZC5C2A73014, 3ZC5C2A76006, 3ZC5C2A76019, 3ZC5C2A76027, 3ZC5C2A77003, 3ZC5C2A7B015, 3ZC5C2A85019, 3ZC5C2A88008, 3ZC5C2A77002, 3ZC5C2A85002, 3ZC5C2A85001, 3ZC5C2A74005, 3ZC5C2A72005, 3ZC5C2A73002, 3ZC5C2A73009, 3ZC5C2A73010, 3ZC5C2A74007, 3ZC5C2A76008, 3ZC5C2A76009, 3ZC5C2A76017, 3ZC5C2A77001, 3ZC5C2A77009, 3ZC5C2A77017, 3ZC5C2A78005, 3ZC5C2A78006, 3ZC5C2A79007, 3ZC5C2A7B008, 3ZC5C2A7B011, 3ZC5C2A7B016, 3ZC5C2A7C014, 3ZC5C2A7C017, 3ZC5C2A81005, 3ZC5C2A81006, 3ZC5C2A81014, 3ZC5C2A84009, 3ZC5C2A85011, 3ZC5C2A85013, 3ZC5C2A75008, 3ZC5C2A85009, 3ZC5C2A7B009, 3ZC5C2A76001, 3ZC5C2A7C009, 3ZC5C2A7C010, 3ZC5C2A87009, 3ZC5C2A7C005, 3ZC5C2A7B013, 3ZC5C2A7B014, 3ZC5C2A73003, 3ZC5C2A77005, 3ZC5C2A74006, 3ZC5C2A81007, 3ZC5C2A75003, 3ZC5C2A72002, 3ZC5C2A72003, 3ZC5C2A72004, 3ZC5C2A72006, 3ZC5C2A73011, 3ZC5C2A74002, 3ZC5C2A75004, 3ZC5C2A76007, 3ZC5C2A76014, 3ZC5C2A76015, 3ZC5C2A77007, 3ZC5C2A77008, 3ZC5C2A77015, 3ZC5C2A77016, 3ZC5C2A77019, 3ZC5C2A77022, 3ZC5C2A79004, 3ZC5C2A7B006, 3ZC5C2A7B012, 3ZC5C2A7B018, 3ZC5C2A7C008, 3ZC5C2A81008, 3ZC5C2A82001, 3ZC5C2A84010, 3ZC5C2A84011, 3ZC5C2A85006, 3ZC5C2A85007, 3ZC5C2A86007, 3ZC5C2A87007, 3ZC5C2A88002, 3ZC5C2A88006, 3ZC5C2A87011, 3ZC5C2A87012, 3ZC5C2A86012, 3ZC5C2A77004, 3ZC5C2A7B003, 3ZC5C2A74008, 3ZC5C2A75001, 3ZC5C2A76011, 3ZC5C2A77021, 3ZC5C2A7B004, 3ZC5C2A7B007, 3ZC5C2A7B010, 3ZC5C2A7C015, 3ZC5C2A85012, 3ZC5C2A86005, 3ZC5C2A87002, 3ZC5C2A87003, 3ZC5C2A76024, 3ZC5C2A77018, 3ZC5C2A79006, 3ZC5C2A81003, 3ZC5C2A82002, 3ZC5C2A86008, 3ZC5C2A87013, 3ZC5C2A88001, 3ZC5C2A77020, 3ZC5C2A83001, 3ZC5C2A85004, 3ZC5C2A85008, 3ZC5C2A73005, 3ZC5C2A78004, 3ZC5C2A79005, 3ZC5C2A7B017, 3ZC5C2A7C001, 3ZC5C2A82003, 3ZC5C2A83004, 3ZC5C2A84001, 3ZC5C2A74010, 3ZC5C2A72001, 3ZC5C2A73004, 3ZC5C2A73008, 3ZC5C2A87005, 3ZC5C2A76004, 3ZC5C2A76025, 3ZC5C2A7A003, 3ZC5C2A7C004, 3ZC5C2A7C011, 3ZC5C2A81011, 3ZC5C2A81013, 3ZC5C2A84003, 3ZC5C2A74001, 3ZC5C2A87004, 3ZC5C2A87006, 3ZC5C2A88004, 3ZC5C2A88007, 3ZC5C2A74003, 3ZC5C2A75010, 3ZC5C2A75011, 3ZC5C2A76003, 3ZC5C2A76005, 3ZC5C2A76012, 3ZC5C2A76020, 3ZC5C2A78001, 3ZC5C2A7C003, 3ZC5C2A81010, 3ZC5C2A84005, 3ZC5C2A84012, 3ZC5C2A71002, 3ZC5C2A71004, 3ZC5C2A73007, 3ZC5C2A74009, 3ZC5C2A76023, 3ZC5C2A7C002, 3ZC5C2A73015, , Model Numbers: CH-200, UDI codes: N/A, Serial Numbers:, 0162M46304, 0162M47002, 0162M48002, 0162M48801, 0162M48902, 0162M48903, 3ZC5C2A21005, 3ZC5C2A4B008, 3ZC5C2A52005, 3ZC5C2A6B011, 0162M46101, 0162M46104, 0162M47505, 0162M47508, 0162M48702, 0162M49006, 0162M49203, 0162M49501, 0162M50007, 0262M49709, 0262M46103, 3ZC5C2A41006, 0362M46501, 0262M48307, 0362M46710, 0362M48206, 0362M49902, 0462M45303, 0462M48001, 0462M48209, 0462M48302, 0462M48902, 3ZC5C2A16003, 3ZC5C2A21006, 3ZC5C2A23017, 3ZC5C2A23019, 3ZC5C2A28011, 3ZC5C2A31002, 3ZC5C2A32006, 3ZC5C2A34003, 3ZC5C2A35018, 3ZC5C2A38016, 3ZC5C2A39004, 3ZC5C2A39005, 3ZC5C2A3A009, 3ZC5C2A3C010, 3ZC5C2A41001, 3ZC5C2A41002, 3ZC5C2A41003, 3ZC5C2A44006, 3ZC5C2A46006, 3ZC5C2A46007, 3ZC5C2A4C009, 3ZC5C2A53011, 3ZC5C2A53013, 3ZC5C2A5C008, 3ZC5C2A5C009, 3ZC5C2A62003, 3ZC5C2A62004, 3ZC5C2A62008, 3ZC5C2A63011, 3ZC5C2A67010, 3ZC5C2A68002, 3ZC5C2A6C003, 3ZC5C2B16001, 3ZC5C2B31001, 0162M45102, 0162M45124, 0162M45127, 0162M45129, 0162M45130, 0162M45131, 0162M45134, 0162M45135, 0162M45137, 0162M45138, 0162M45144, 0162M45145, 0162M46105, 0162M46106, 0162M46109, 0162M46110, 0162M46210, 0162M46301, 0162M46305, 0162M46605, 0162M46606, 0162M46608, 0162M46708, 0162M47003, 0162M47004, 0162M47306, 0162M47308, 0162M47402, 0162M47404, 0162M47406, 0162M47407, 0162M47509, 0162M47902, 0162M47905, 0162M47909, 0162M48003, 0162M48510, 0162M48802, 0162M48907, 0162M48909, 0162M49005, 0162M49704, 0262M45502, 0262M45503, 0262M45504, 0262M45703, 0262M45704, 0262M45705, 0262M45706, 0262M45710, 0262M45803, 0262M46007, 0262M47207, 0262M47209, 0262M47406, 0262M46104, 0262M47205, 0462M49105, 0262M47505, 0262M47506, 0262M47706, 0262M47707, 0262M47806, 3ZC5C2A45017, 0262M48003, 0362M49305, 0262M48101, 3ZC5C2A2B014, 3ZC5C2A37005, 3ZC5C2A53008, 3ZC5C2A53007, 0262M48107, 0262M48108, 0262M48109, 3ZC5C2A48015, 0262M48208, 0262M48301, 0262M48305, 0262M48306, 0462M48207, 0262M48806, 0462M48301, 0462M48304, 0262M49203, 0262M49204, 0362M46103, 3ZC5C2A45015, 3ZC5C2A57010, 3ZC5C2A31004, 0462M49607, 0262M49210, 0262M49701, 0262M49702, 3ZC5C2A12005, 3ZC5C2A1100A, 3ZC5C2A1A004, 3ZC5C2A0A00A, 0262M49808, 0262M48106, 3ZC5C2A0C005, 0462M50002, 3ZC5C2A16007, 0462M46401, 3ZC5C2A63010, 3ZC5C2A26002, 0362M45403, 0362M45404, 0462M49104, 3ZC5C2A28007, 3ZC5C2A1C009, 3ZC5C2A14007, 3ZC5C2B22001, 0362M50005, 0362M45705, 3ZC5C2A2B015, 0362M46102, 0262M47408, 3ZC5C2A37012, 3ZC5C2A23003, 0362M49905, 0462M47601, 3ZC5C2A47010, 0362M48203, 0362M47109, 0362M48304, 0362M46603, 0362M46708, 0362M47501, 0362M47902, 0362M48204, 0362M46707, 0362M50003, 0362M48305, 0562M45606, 3ZC5C2A33008, 3ZC5C2A1C004, 3ZC5C2A27001, 3ZC5C2A18008, 3ZC5C2A36006, 3ZC5C2A16009, 0462M47409, 3ZC5C2A36004, 3ZC5C2A66011, 3ZC5C2A2C001, 0362M47502, 0362M47503, 0262M48804, 0362M49709, 0462M46101, 0262M49001, 0262M49006, 0362M48302, 3ZC5C2A0A009, 0362M47507, 0362M47903, 3ZC5C2A0A003, 3ZC5C2A62005, 0462M49006, 3ZC5C2A16010, 3ZC5C2A51005, 3ZC5C2A46008, 3ZC5C2B2B003, 0362M45401, 0362M46607, 3ZC5C2A2C010, 0262M48202, 0362M49306, 3ZC5C2A0A007, 0462M49609, 0362M45704, 0462M47802, 0462M47803, 3ZC5C2A38005, 3ZC5C2A2C012, 0362M47104, 0362M49304, 3ZC5C2A47008, 3ZC5C2A57017, 3ZC5C2A64017, 3ZC5C2A6C014, 3ZC5C2A25006, 3ZC5C2A44013, 3ZC5C2A1C008, 3ZC5C2A57015, 3ZC5C2A2C004, 3ZC5C2A27002, 3ZC5C2A19003, 3ZC5C2A49009, 3ZC5C2A12002, 0462M47101, 0362M47908, 0462M47103, 0262M49207, 0262M49209, 0262M49906, 0462M47809, 0462M47704, 0462M46102, 3ZC5C2A21001, 3ZC5C2A61004, 0462M47603, 3ZC5C2A2C002, 0362M46201, 0362M49707, 0362M49906, 0462M45304, 0562M45302, 3ZC5C2A38003, 0462M46605, 0462M47705, 3ZC5C2A46012, 3ZC5C2A4B010, 3ZC5C2A5B009, 0462M47801, 0262M49206, 0462M47901, 0262M49706, 0262M49907, 0362M45703, 0462M48206, 0362M46709, 0262M49007, 0362M45405, 0362M45410, 0362M47201, 3ZC5C2A66012, 3ZC5C2A49005, 0462M48905, 3ZC5C2A5B008, 3ZC5C2A5A001, 0362M46703, 0362M46706, 3ZC5C2A12007, 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3ZC5C2A41010, 3ZC5C2A41012, 3ZC5C2A41009, 3ZC5C2A41011, 3ZC5C2A44003, 3ZC5C2A44002, 3ZC5C2A31010, 3ZC5C2A63016, 3ZC5C2A63018, 3ZC5C2A64004, 3ZC5C2A52009, 3ZC5C2A22015, 3ZC5C2A33006, 3ZC5C2A0B004, 3ZC5C2A58002, 0362M49506, 3ZC5C2A38007, 3ZC5C2A3A001, 0362M46601, 0362M46704, 3ZC5C2A1B009, 0562M45303, 3ZC5C2A22003, 3ZC5C2A48018, 3ZC5C2A1B014, 3ZC5C2A1B008, 0362M47804, 0362M47905, 3ZC5C2A4A005, 3ZC5C2A48010, 3ZC5C2A4B004, 3ZC5C2A2B010, 3ZC5C2A31012, 3ZC5C2A32001, 3ZC5C2A34001, 3ZC5C2A45011, 3ZC5C2A47002, 3ZC5C2A54004, 3ZC5C2A23010, 3ZC5C2A48004, 3ZC5C2A65006, 3ZC5C2A35017, 3ZC5C2A69009, 0262M48303, 3ZC5C2A47004, 3ZC5C2A24010, 0262M49002, 0462M47707, 0462M47708, 3ZC5C2A63002, 3ZC5C2A48022, 3ZC5C2A2B003, 0462M46302, 3ZC5C2A47016, 0462M49007, 0362M49301, 3ZC5C2A48007, 3ZC5C2A21002, 3ZC5C2A38012, 0262M46702, 0262M48103, 0262M48302, , Model Numbers: CH-200M, UDI codes: 04540217050826, Serial Numbers:, 41E733E74005, 41E733E72003, 41E733E85002, 41E733E86001, 41E733E86002, 41E733E86003, 41E733E86004, 41E733E88001, 41E733E72001, 41E733E72002, 41E733E72005, 41E733E74001, 41E733E74003, 41E733E74004, 41E733E85001, 41E733E88002, 41E733E88003, 41E733E72004, 41E733E86005, 41E733E74002, 41E733E88004, , Model Numbers: CH-200M, UDI codes: N/A, Serial Numbers:, 0262M42603, 0362M44102, 0462M43402, 0462M43403, 0562M43907, 0362M44701, 41E733E67002, 41E733E64004, 41E733E65001, 41E733E63005, 3ZC5C1661001, 41E733E64001, 41E733E6B004, 0462M40101, 3ZC5C160C005, 0662M41305, 0562M42808, 3ZC5C1653001, 3ZC5C1652002, 0662M40807, 0662M40806, 0662M40401, 0362M44502, 0462M43404, 3ZC5C1632004, 0262M40510, 3ZC5C1617001, 0462M45001, 0462M45003, 0562M44901, 3ZC5C1645001, 3ZC5C1645002, 3ZC5C1612005, 3ZC5C162C001, 3ZC5C162A001, 0662M41303, 0562M42805, 3ZC5C1622001, 0562M40701, 3ZC5C160C007, 3ZC5C1635002, 0362M44702, 0362M44703, 3ZC5C162B002, 0262M44906, 0162M43610, 0162M43613, 0162M43618, 0162M43619, 0162M43620, 0162M43916, 0162M44409, 0162M44509, 0262M40509, 0262M40610, 0262M41609, 0262M43904, 0262M44301, 0262M44302, 0262M44303, 0262M44408, 0362M40801, 0362M40802, 0362M40803, 0362M41407, 0362M41409, 0362M42404, 0462M40103, 0462M41202, 0562M42806, 0662M40808, 3ZC5C160C006, 3ZC5C1612002, 3ZC5C1613002, 3ZC5C1615001, 3ZC5C161B003, 3ZC5C1623002, 3ZC5C1631002, 3ZC5C1643002, 3ZC5C1643003, 3ZC5C1643005, 41E733E63001, 41E733E67001, 41E733E67005, 41E733E6B001, 41E733E6B009, 0462M40102, 3ZC5C160C004, 41E733E67004, 3ZC5C1645004, 3ZC5C162A002, 0462M41201, 3ZC5C1616004, 3ZC5C162B001, 3ZC5C1636001, 3ZC5C160C003, 0662M40809, 3ZC5C1616001, 3ZC5C1654001, 0462M41602, 3ZC5C1629005, 3ZC5C161A001, 0462M40202, 3ZC5C162A004, 0362M40510, 0462M44204, 3ZC5C1646002, 0162M43015, 0162M43016, 0162M43218, 0162M43614, 0262M40507, 0262M40710, 0262M42604, 0362M42405, 0562M43906, 3ZC5C164C002, 0362M43603, 3ZC5C1612004, 41E733E69005, 3ZC5C161A002, 3ZC5C1635001, 3ZC5C1629003, 3ZC5C1623003, 3ZC5C1629001, 3ZC5C1616003, 0462M42002, 3ZC5C1632002, 0162M43017, 0162M43612, 0262M40508, 0262M40607, 0262M43602, 0462M41701, 0462M43202, 0462M45002, 0562M40702, 0562M43110, 3ZC5C1638001, 3ZC5C164A002, 3ZC5C1655002, 41E733E6B003, 3ZC5C164A001, 41E733E64003, 3ZC5C161B001, 3ZC5C1625001, 3ZC5C1648001, 0362M44501, 3ZC5C1659001, 41E733E63003, 3ZC5C1652001, 3ZC5C1641001, 0362M44704, 3ZC5C1631001, 3ZC5C160C001, 3ZC5C1612003, 0162M42920, 0162M43611, 0162M43616, 0262M40506, 0262M42801, 0262M42901, 0462M41204, 0462M43001, 0462M44202, 3ZC5C1629004, 3ZC5C1632003, 3ZC5C1633001, 41E733E6A001, 41E733E6B002, 41E733E69002, 0562M42608, 41E733E64002, 3ZC5C164C001, 0262M44403, 0362M43601, 3ZC5C1637001, 3ZC5C1637002, 41E733E63002, 3ZC5C162C002, 3ZC5C162A003, 0462M41203, 0362M44104, 0462M41601, 0262M44205, 0462M40201, 0462M44203, 0262M44409, 0462M42001, 0362M41408, 0662M41304, 0162M43615, 0262M43202, 0262M43510, 0262M44407, 3ZC5C1632001, 3ZC5C1628002, 0462M43002, 0162M43617, 0462M42402, 3ZC5C1616002, 0562M42804, 3ZC5C1612006, 3ZC5C1641002, 3ZC5C1623004, 3ZC5C1637003, 3ZC5C161B002, 3ZC5C1612008, 0562M42807, 0362M43002, 0262M42709, 0262M44304, 0262M44204, 0362M44905, 3ZC5C1612007, 3ZC5C1655001, 3ZC5C1661002, 41E733E69004, 0462M43401, 0462M43406, 0462M42104, 0462M43405, 0462M44002, 0462M45004, 0462M43201, 0162M43518, 0162M44510, 0262M43905, 3ZC5C1633002, 0362M41101, 0362M42303, 0362M42403, 0362M43604, 0362M44103, 3ZC5C1636002, 3ZC5C1629002, 3ZC5C1643004, 3ZC5C1613001, 0462M43803, 0462M44205, 0562M41105, 0662M40601, 3ZC5C1612001, 3ZC5C1623001, 0562M42803, 41E733E63004, 41E733E69001, 3ZC5C163A001, 3ZC5C1645003, 3ZC5C1648002, 0462M42105, 41E733E67003, 0462M41205, 3ZC5C1717001, 3ZC5C1628001, 41E733E6B006, 0262M44203, 0262M44807, 41E733E6B005, 41E733E6B007, 41E733E6B008.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Shimadzu Corporation Medical Systems Division

All 6

Reported	Class	Recall	Company	Reason	Where
13 Nov 2024Device	CLASS II	The FLUOROspeed is intended to be used as a universal recalled	Shimadzu Corporation Medical Systems Division	Device Malfunction	Nationwide
13 Nov 2024Device	CLASS II	Sonialvision G4 is a multi-purpose X-ray R/F system recalled	Shimadzu Corporation Medical Systems Division	Device Malfunction	Nationwide
30 Oct 2024Device	CLASS II	Trinias unity, Digital Angiography System with Catheterization Table recalled	Shimadzu Corporation Medical Systems Division	Other	Nationwide
20 Mar 2024Device	CLASS II	Shimadzu, Trinias, Digital Angiography System recalled	Shimadzu Corporation Medical Systems Division	Other	Nationwide
9 Aug 2023Device	CLASS II	Over-Head Ceiling Tube Support, CH-200, CH-200M, Used recalled	Shimadzu Corporation Medical Systems Division	Other	Nationwide

Other Imaging Equipment recalls

All 2,336

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep Clear recalled	Medline Industries	Packaging Defects	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits: Ultrasound Breast Pack recalled	Medline Industries	Sterility	Nationwide
2 Sep 2026Device	CLASS II	Alphenix Models Infx-8000C Infx-8000F Infx-8000V This device recalled	Canon Medical System USA	Other	Nationwide
2 Sep 2026Device	CLASS II	Merge PACS and Merge OrthoPACS recalled by Merge Healthcare	Merge Healthcare	Labeling Errors	Nationwide
19 Aug 2026Device	CLASS II	Philips Azurion recalled by Philips Medical Systems	Philips Medical Systems Nederl	Potency & Assay