CLASS II Device recall · Reported 4 May 2016 · FDA Enforcement Report

X-Ray Diagnostic Table recalled by Shimadzu Medical Systems

Shimadzu Medical Systems is recalling X-Ray Diagnostic Table, distributed nationwide in the US. The recall was initiated on 31 Mar 2016 and the FDA has classified it as Class II.

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Lot, batch or date codesSerial No. 0162A80301 0162A80302 0162A80303 0162A80401 0162A80403 0162A81001 0162A81002 0162A81003 0162A81101 0162A81102 0162A81103 0162A81104 0162A81105 0162A81106 0162A81301 0162A81302 0162A81303 0162A81304 0162A81501 0162A81502 0162A81503 0162A81504 0162A81505 0162A81601 0162A81602 0162A81603 0162A81701 0162A81702 0162A81703 0162A81704 0162A81705 0162A81801 0162A81803 0162A82101 0162A82102 0162A82202 0162A82203 0162A82301 0162A82302 0162A82501 0162A82502 0162A82601 0162A82602 0162A82701 0162A82702 0162A82703 0162A82801 0162A82802 0162A82902 0162A83001 0162A83002 0162A83101 0162A83201 0162A83202 0162A83301 0162A83302 0162A83401 0162A83501 0162A83502 0162A83601 0162A83602 0162A83702 0162A83801 0162A83901 0162A83902 0162A84001 0162A84101 0162A84102 0162A84201 0162A84202 0162A84203 0162A84301 0162A84302 0162A84401 0162A84402 0162A84501 0162A84502 0162A84601 0162A84602 0162A84701 0162A84702 0162A84802 0162A84901 0162A84902 0162A85001 0162A85002 0262A80101 0262A80102 0262A80201 0262A80202 0262A80301 0262A80302 0262A80501 0262A80502 0262A80701 0262A80702 0262A80801 0262A80802 0262A80901 0262A80902 0262A81001 0262A81101 0262A81202 0262A81301 0262A81302 0262A81401 0262A81402 0262A81501 0262A81502 0262A81601 0262A81701 0262A81702 0262A81801 0262A81802 0262A81902 0262A82002 0262A82101 0262A82102 0262A82201 0262A82202 0262A82402 0262A82502 0262A82601 0262A82701 0262A82702 0262A82901 0262A83201 0262A83202 0262A83401 0262A83501 0262A83502 0262A83602 0262A83701 0262A83702 0262A83801 0262A83802 0262A83902 0262A84101 0262A84102 0262A84201 0262A84302 0262A84401 0262A84501 0262A84502 3YAFC840A002 3YAFC840A003 3YAFC840A004 3YAFC8411001 3YAFC8413001 3YAFC8415001 3YAFC8415002 3YAFC8418001 3YAFC8418002 3YAFC841A001 3YAFC841A002 3YAFC841B001 3YAFC841B002 3YAFC841C001 3YAFC841C002 3YAFC8422001 3YAFC8422002 3YAFC8422003 3YAFC8425001 3YAFC8425002 3YAFC8427001 3YAFC8427002 3YAFC8427003 3YAFC8428001 3YAFC8428002 3YAFC8428003 3YAFC8428004 3YAFC842A001 3YAFC842A002 3YAFC842C001 3YAFC842C002 3YAFC8433001 3YAFC8442001 3YAFC8443001 3YAFC8444001 3YAFC8446001 3YAFC8448001 3YAFC8449001 3YAFC8453001 3YAFC8458001 0262A84301

Quantity recalled185 units

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-1585-2016
FDA event ID: 73745
Recalling firm: Shimadzu Medical Systems, Torrance, CA
Classification: Class II
Status: Terminated
Recall initiated: 31 Mar 2016
FDA classified: 28 Apr 2016
Reported: 4 May 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

31 Mar 2016	Recall initiated by company
28 Apr 2016	Classified by FDA	+28 days
4 May 2016	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

Report of unintentional movement of table to reverse tilting.

Product as listed by the FDA

X-Ray Diagnostic Table, Model No. YSF-300 Use in combination with an X-ray high voltage generator, an X-ray tube unit, an Image intensifier and X-ray television unit, this table is applied for the following X-ray examinations: -X-ray T.V. fluoroscopy -Spot-filming -Bucky radiography

Where it was distributed

Nationwide Distribution

Nationwide

Questions about this recall

Is X-Ray Diagnostic Table recalled?

Yes. Shimadzu Medical Systems recalled X-Ray Diagnostic Table on 31 Mar 2016. The recall is Class II and its status is Terminated. Recall number Z-1585-2016.

Why was it recalled?

Report of unintentional movement of table to reverse tilting.

Which lots are affected?

Serial No. 0162A80301 0162A80302 0162A80303 0162A80401 0162A80403 0162A81001 0162A81002 0162A81003 0162A81101 0162A81102 0162A81103 0162A81104 0162A81105 0162A81106 0162A81301 0162A81302 0162A81303 0162A81304 0162A81501 0162A81502 0162A81503 0162A81504 0162A81505 0162A81601 0162A81602 0162A81603 0162A81701 0162A81702 0162A81703 0162A81704 0162A81705 0162A81801 0162A81803 0162A82101 0162A82102 0162A82202 0162A82203 0162A82301 0162A82302 0162A82501 0162A82502 0162A82601 0162A82602 0162A82701 0162A82702 0162A82703 0162A82801 0162A82802 0162A82902 0162A83001 0162A83002 0162A83101 0162A83201 0162A83202 0162A83301 0162A83302 0162A83401 0162A83501 0162A83502 0162A83601 0162A83602 0162A83702 0162A83801 0162A83901 0162A83902 0162A84001 0162A84101 0162A84102 0162A84201 0162A84202 0162A84203 0162A84301 0162A84302 0162A84401 0162A84402 0162A84501 0162A84502 0162A84601 0162A84602 0162A84701 0162A84702 0162A84802 0162A84901 0162A84902 0162A85001 0162A85002 0262A80101 0262A80102 0262A80201 0262A80202 0262A80301 0262A80302 0262A80501 0262A80502 0262A80701 0262A80702 0262A80801 0262A80802 0262A80901 0262A80902 0262A81001 0262A81101 0262A81202 0262A81301 0262A81302 0262A81401 0262A81402 0262A81501 0262A81502 0262A81601 0262A81701 0262A81702 0262A81801 0262A81802 0262A81902 0262A82002 0262A82101 0262A82102 0262A82201 0262A82202 0262A82402 0262A82502 0262A82601 0262A82701 0262A82702 0262A82901 0262A83201 0262A83202 0262A83401 0262A83501 0262A83502 0262A83602 0262A83701 0262A83702 0262A83801 0262A83802 0262A83902 0262A84101 0262A84102 0262A84201 0262A84302 0262A84401 0262A84501 0262A84502 3YAFC840A002 3YAFC840A003 3YAFC840A004 3YAFC8411001 3YAFC8413001 3YAFC8415001 3YAFC8415002 3YAFC8418001 3YAFC8418002 3YAFC841A001 3YAFC841A002 3YAFC841B001 3YAFC841B002 3YAFC841C001 3YAFC841C002 3YAFC8422001 3YAFC8422002 3YAFC8422003 3YAFC8425001 3YAFC8425002 3YAFC8427001 3YAFC8427002 3YAFC8427003 3YAFC8428001 3YAFC8428002 3YAFC8428003 3YAFC8428004 3YAFC842A001 3YAFC842A002 3YAFC842C001 3YAFC842C002 3YAFC8433001 3YAFC8442001 3YAFC8443001 3YAFC8444001 3YAFC8446001 3YAFC8448001 3YAFC8449001 3YAFC8453001 3YAFC8458001 0262A84301

Where was it sold?

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

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