CLASS II ONGOING Device recall · Reported 9 Aug 2023 · FDA Enforcement Report

Over-Head Ceiling Tube Support, CH-200, CH-200M, Used recalled

Shimadzu Corporation Medical Systems Division is recalling Over-Head Ceiling Tube Support, CH-200, CH-200M, Used with RadSpeed and RadSpeed PRO, distributed nationwide in the US. The recall was initiated on 10 Apr 2023 and the FDA has classified it as Class II.

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Lot, batch or date codesAll manufactured prior to August 1,2019. REF/UDI-DI/Serial Numbers: CH-200/04540217031436/0162M46304, 0162M48002, 0162M48801, 0162M48902, 0162M48903, 3ZC5C2A21005, 3ZC5C2A4B008, 3ZC5C2A52005, 3ZC5C2A6B011, 3ZC5C2A84014, 3ZC5C2A85003, 3ZC5C2A88019, 3ZC5C2A91005, 3ZC5C2A92004, 0162M46101, 0162M46104, 0162M47505, 0162M47508, 0162M48702, 0162M49006, 0162M49203, 0162M49501, 0162M50007, 0262M46103, 0262M48307, 0262M49709, 0362M46501, 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, 3ZC5C2A41006, 3ZC5C2A44006, 3ZC5C2A46006, 3ZC5C2A46007, 3ZC5C2A4C009, 3ZC5C2A53011, 3ZC5C2A53013, 3ZC5C2A5C008, 3ZC5C2A5C009, 3ZC5C2A62003, 3ZC5C2A62004, 3ZC5C2A62008, 3ZC5C2A63011, 3ZC5C2A67010, 3ZC5C2A68002, 3ZC5C2A6C003, 3ZC5C2A75012, 3ZC5C2A76002, 3ZC5C2A76016, 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41E733E86003, 41E733E86004, 41E733E88001, 0162M43015, 0162M43016, 0162M43218, 0162M43614, 0262M40507, 0262M40710, 0262M42604, 0362M40510, 0362M42405, 0462M40102, 0462M41201, 0462M41602, 0462M44204, 0562M43906, 0662M40809, 3ZC5C160C003, 3ZC5C160C004, 3ZC5C1616001, 3ZC5C1616004, 3ZC5C161A001, 3ZC5C1629005, 3ZC5C162A002, 3ZC5C162A004, 3ZC5C162B001, 3ZC5C1636001, 3ZC5C1645004, 3ZC5C1646002, 3ZC5C164C002, 3ZC5C1654001, 41E733E67004, 41E733E72001, 41E733E72002, 41E733E72005, 41E733E74001, 41E733E74003, 0162M43017, 0162M43612, 0262M40508, 0262M40607, 0262M43602, 0362M43603, 0462M41701, 0462M42002, 0462M43202, 0462M45002, 0562M40702, 0562M43110, 3ZC5C1612004, 3ZC5C1616003, 3ZC5C161A002, 3ZC5C1623003, 3ZC5C1629003, 3ZC5C1632002, 3ZC5C1635001, 3ZC5C1638001, 3ZC5C164A002, 3ZC5C1655002, 41E733E69005, 41E733E6B003, 41E733E74004, 41E733E85001, 0162M43615, 0262M43202, 0262M43510, 0262M44407, 0262M44409, 0362M41408, 0462M42001, 0662M41304, 0162M42920, 0162M43611, 0162M43616, 0262M40506, 0262M42801, 0262M42901, 0362M44501, 0362M44704, 0462M41204, 0462M43001, 0462M44202, 3ZC5C160C001, 3ZC5C1612003, 3ZC5C161B001, 3ZC5C1625001, 3ZC5C1629004, 3ZC5C1631001, 3ZC5C1632003, 3ZC5C1633001, 3ZC5C1641001, 3ZC5C1648001, 3ZC5C164A001, 3ZC5C1652001, 3ZC5C1659001, 41E733E63003, 41E733E64003, 41E733E6A001, 41E733E6B002, 0262M43905, 0262M44403, 0362M43601, 0562M42608, 3ZC5C1637001, 3ZC5C1637002, 3ZC5C164C001, 41E733E63002, 41E733E64002, 41E733E69002, 3ZC5C162A003, 3ZC5C162C002, 41E733E88002, 41E733E88003, LZC5C4C96006, 0462M41203, 0262M44205, 0362M44104, 0462M40201, 0462M41601, 0462M44203, 0162M43617, 0462M42402, 0462M43002, 3ZC5C1628002, 3ZC5C1629001, 3ZC5C1632001, 0262M42709, 0262M44204, 0262M44304, 0362M43002, 0362M44905, 0562M42804, 0562M42807, 3ZC5C1612006, 3ZC5C1612007, 3ZC5C1612008, 3ZC5C1616002, 3ZC5C161B002, 3ZC5C1623004, 3ZC5C1637003, 3ZC5C1641002, 3ZC5C1655001, 3ZC5C1661002, 41E733E69004, 41E733E72004, 41E733E86005, 41E733E8C003, LZC5C4C96009, 0162M43518, 0162M44510, 0262M44203, 0262M44807, 0362M41101, 0362M42303, 0362M42403, 0362M43604, 0362M44103, 0462M41205, 0462M42104, 0462M42105, 0462M43201, 0462M43401, 0462M43405, 0462M43406, 0462M43803, 0462M44002, 0462M44205, 0462M45004, 0562M41105, 0562M42803, 0662M40601, 3ZC5C1612001, 3ZC5C1613001, 3ZC5C1623001, 3ZC5C1628001, 3ZC5C1629002, 3ZC5C1633002, 3ZC5C1636002, 3ZC5C163A001, 3ZC5C1643004, 3ZC5C1645003, 3ZC5C1648002, 3ZC5C1717001, 41E733E63004, 41E733E67003, 41E733E69001, 41E733E6B005, 41E733E6B006, 41E733E6B007, 41E733E6B008, 41E733E74002, 41E733E88004, 41E733E8A001, 41E733E8C001, 41E733E8C002

Quantity recalled1836

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-2270-2023
FDA event ID: 92391
Recalling firm: Shimadzu Corporation Medical Systems Division, Kyoto, N/A
Classification: Class II
Status: Ongoing
Recall initiated: 10 Apr 2023
FDA classified: 31 Jul 2023
Reported: 9 Aug 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

10 Apr 2023	Recall initiated by company
31 Jul 2023	Classified by FDA	+112 days
9 Aug 2023	Published in enforcement report	+9 days

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

Reason for recall

Eight fixing bolts at the base of the X-ray ceiling tube column assembly may be loose or missing so service is required to install a cable, bracket, and label behind the bracket, indicating when service is required, to eliminate the risk of the device falling.

Product as listed by the FDA

Over-Head Ceiling Tube Support, CH-200, CH-200M, Used with RadSpeed and RadSpeed PRO, Sonial Vision safire, Versa and G4 units, FluoroSpeed 300 and X1 units

Where it was distributed

U.S. Nationwide distribution.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

All manufactured prior to August 1,2019. REF/UDI-DI/Serial Numbers: CH-200/04540217031436/0162M46304, 0162M48002, 0162M48801, 0162M48902, 0162M48903, 3ZC5C2A21005, 3ZC5C2A4B008, 3ZC5C2A52005, 3ZC5C2A6B011, 3ZC5C2A84014, 3ZC5C2A85003, 3ZC5C2A88019, 3ZC5C2A91005, 3ZC5C2A92004, 0162M46101, 0162M46104, 0162M47505, 0162M47508, 0162M48702, 0162M49006, 0162M49203, 0162M49501, 0162M50007, 0262M46103, 0262M48307, 0262M49709, 0362M46501, 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, 3ZC5C2A41006, 3ZC5C2A44006, 3ZC5C2A46006, 3ZC5C2A46007, 3ZC5C2A4C009, 3ZC5C2A53011, 3ZC5C2A53013, 3ZC5C2A5C008, 3ZC5C2A5C009, 3ZC5C2A62003, 3ZC5C2A62004, 3ZC5C2A62008, 3ZC5C2A63011, 3ZC5C2A67010, 3ZC5C2A68002, 3ZC5C2A6C003, 3ZC5C2A75012, 3ZC5C2A76002, 3ZC5C2A76016, 3ZC5C2A76026, 3ZC5C2A77013, 3ZC5C2A79003, 3ZC5C2A84008, 3ZC5C2A86013, 3ZC5C2A8A012, 3ZC5C2B16001, 3ZC5C2B31001, LZC5C5196031, 0162M45119, 0162M45123, 0162M45124, 0162M45127, 0162M45129, 0162M45131, 0162M45134, 0162M45135, 0162M45137, 0162M45138, 0162M45144, 0162M45145, 0162M46105, 0162M46106, 0162M46109, 0162M46110, 0162M46210, 0162M46606, 0162M46608, 0162M46708, 0162M47003, 0162M47004, 0162M47306, 0162M47308, 0162M47402, 0162M47404, 0162M47406, 0162M47407, 0162M47507, 0162M47509, 0162M47902, 0162M47905, 0162M47909, 0162M48510, 0162M48802, 0162M48807, 0162M48904, 0162M48907, 0162M48909, 0162M49005, 0162M49704, 0262M45502, 0262M45503, 0262M45504, 0262M45703, 0262M45704, 0262M45705, 0262M45706, 0262M45710, 0262M45803, 0262M46007, 0262M46104, 0262M47205, 0262M47207, 0262M47209, 0262M47406, 0262M47408, 0262M47503, 0262M47504, 0262M47506, 0262M47706, 0262M47707, 0262M47806, 0262M48003, 0262M48101, 0262M48106, 0262M48107, 0262M48108, 0262M48109, 0262M48202, 0262M48205, 0262M48208, 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3ZC5C2A1A004, 3ZC5C2A1A005, 3ZC5C2A1C001, 3ZC5C2A1C002, 3ZC5C2A1C004, 3ZC5C2A1C006, 3ZC5C2A1C008, 3ZC5C2A1C009, 3ZC5C2A21001, 3ZC5C2A21013, 3ZC5C2A21014, 3ZC5C2A22002, 3ZC5C2A22016, 3ZC5C2A22017, 3ZC5C2A23001, 3ZC5C2A23003, 3ZC5C2A24001, 3ZC5C2A24002, 3ZC5C2A24012, 3ZC5C2A25004, 3ZC5C2A25006, 3ZC5C2A26002, 3ZC5C2A26003, 3ZC5C2A27001, 3ZC5C2A27002, 3ZC5C2A28006, 3ZC5C2A28007, 3ZC5C2A2B009, 3ZC5C2A2B014, 3ZC5C2A2B015, 3ZC5C2A2B016, 3ZC5C2A2B017, 3ZC5C2A2C001, 3ZC5C2A2C002, 3ZC5C2A2C003, 3ZC5C2A2C004, 3ZC5C2A2C005, 3ZC5C2A2C010, 3ZC5C2A2C012, 3ZC5C2A31003, 3ZC5C2A31004, 3ZC5C2A32005, 3ZC5C2A33004, 3ZC5C2A33008, 3ZC5C2A34002, 3ZC5C2A35019, 3ZC5C2A36003, 3ZC5C2A36004, 3ZC5C2A36006, 3ZC5C2A37005, 3ZC5C2A37012, 3ZC5C2A38003, 3ZC5C2A38004, 3ZC5C2A38005, 3ZC5C2A3B001, 3ZC5C2A43003, 3ZC5C2A43006, 3ZC5C2A44013, 3ZC5C2A45015, 3ZC5C2A45016, 3ZC5C2A45017, 3ZC5C2A46008, 3ZC5C2A46012, 3ZC5C2A47006, 3ZC5C2A47008, 3ZC5C2A47010, 3ZC5C2A48005, 3ZC5C2A48015, 3ZC5C2A48020, 3ZC5C2A49001, 3ZC5C2A49005, 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Where was it sold?

U.S. Nationwide distribution.

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
19 Nov 2025Device	CLASS II	Ceiling Type X-Ray Tube Support recalled by Shimadzu Corporation Medical	Shimadzu Corporation Medical Systems Division	Device Malfunction	Nationwide
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

Other Other Medical Devices recalls

All 13,778

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide