CLASS II Device recall · Reported 4 Jan 2017 · FDA Enforcement Report

Shimadzu X-ray High Voltage Generator recalled

Shimadzu Medical Systems is recalling Shimadzu X-ray High Voltage Generator, distributed in 7 states. The recall was initiated on 20 Nov 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial No. 3M5249D1C013 3M5249D22013 3M5249D29002 3M5249D2A004 3M5249D2C004 3M5249D31009 3M5249D32012 3M5249D33003 3M5249D34001 3M5249D35002 3M5249D37006 3M5249D41006 3M5249D46003

Quantity recalled13 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-0918-2017
FDA event ID: 75834
Recalling firm: Shimadzu Medical Systems, Torrance, CA
Classification: Class II
Status: Terminated
Recall initiated: 20 Nov 2016
FDA classified: 23 Dec 2016
Reported: 4 Jan 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Imaging Equipment

Timeline

20 Nov 2016	Recall initiated by company
23 Dec 2016	Classified by FDA	+33 days
4 Jan 2017	Published in enforcement report	+12 days

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

Reason for recall

Shimadzu Medical Systems is recalling the Shimadzu X-ray High Voltage Generator due to the possibility of oil leaking from the x-ray tube housing under certain conditions.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Shimadzu X-ray High Voltage Generator Model No. UD150B-40 on SONIALVISION safire II/17 systems with 0.7/1.2JG326D X-Ray Tube Diagnostic x-ray high voltage generator.

Where it was distributed

US Distribution to states of: AZ, WA, CA, LA, FL, SC, and NJ.

Arizona California Florida Louisiana New Jersey South Carolina Washington

Questions about this recall

Is Shimadzu X-ray High Voltage Generator recalled?

Yes. Shimadzu Medical Systems recalled Shimadzu X-ray High Voltage Generator on 20 Nov 2016. The recall is Class II and its status is Terminated. Recall number Z-0918-2017.

Why was it recalled?

Shimadzu Medical Systems is recalling the Shimadzu X-ray High Voltage Generator due to the possibility of oil leaking from the x-ray tube housing under certain conditions.

Which lots are affected?

Serial No. 3M5249D1C013 3M5249D22013 3M5249D29002 3M5249D2A004 3M5249D2C004 3M5249D31009 3M5249D32012 3M5249D33003 3M5249D34001 3M5249D35002 3M5249D37006 3M5249D41006 3M5249D46003

Where was it sold?

US Distribution to states of: AZ, WA, CA, LA, FL, SC, and NJ.

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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