CLASS II ONGOING Device recall · Reported 9 Mar 2022 · FDA Enforcement Report

Digital Angiography System Shimadzu Trinias Generator recalled

Shimadzu Medical Systems is recalling Digital Angiography System Shimadzu Trinias Generator, distributed in 15 states. The recall was initiated on 16 Dec 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesGenerator Model: D150GC-40 Serial Number Range - 3M99D44446001to LM99D44B8001 Serial Number/SMS ID: 41E58C765001/SMS20160146 41EFCD78B001/SMS20190007 41EFD3B9A001/SMS20200009 41F005CB8001/SMS20210266 41E58C766001/SMS20160150 41B247746001/SMS20140089 41E58C757001/SMSHP150024 41E58C769001/SMS20160151 41E58C777001/SMS20170121 41EFCD77C001/SMS20180143 41F005B8C001/SMS20190052 41EFCD79A001/SMS20190366 41EFCD79C001/SMS20200285 41EFC73A5001/SMS20200263 41EFCD7A6001/SMS20200267 41EFC73A9001/SMS20200443 41E5E23AA001/SMS20200369 41E58C773001/SMSHP170001 41E58C977001/SMS20170424 41EFFF79A001/SMS20190376 41EFFF79C001/SMS20200031 41EFD3B9C001/SMS20200066 41E58C76B001/SMS20170288 41E58C775001/SMS20170134 41E58C776001/SMS20170135 41F005B91001/SMS20190019 41B24774C001/SMSMA140084 41EFCD7AC001/#N/A

Quantity recalled28 systems

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-0655-2022
FDA event ID: 89253
Recalling firm: Shimadzu Medical Systems, Torrance, CA
Classification: Class II
Status: Ongoing
Recall initiated: 16 Dec 2021
FDA classified: 27 Feb 2022
Reported: 9 Mar 2022
Type: FDA Mandated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

16 Dec 2021	Recall initiated by company
27 Feb 2022	Classified by FDA	+73 days
9 Mar 2022	Published in enforcement report	+10 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 the inadequate adjusting criteria in installation, the system generator on two Digital Angiography Systems, the irradiated x-ray may exceed the x-ray radiation dose rate in fluoroscopic mode.

Product as listed by the FDA

Digital Angiography System Shimadzu Trinias Generator Model: D150GC-40

Where it was distributed

U.S.: CA, FL, GA, IL, IN, KY, LA, MI, MS, OH, PA, SC, TN, TX and WA O.U.S.: Not provided.

California Florida Georgia Illinois Indiana Kentucky Louisiana Michigan Mississippi Ohio Pennsylvania South Carolina Tennessee Texas Washington

Stores named: Walmart

Questions about this recall

Is Digital Angiography System Shimadzu Trinias Generator recalled?

Yes. Shimadzu Medical Systems recalled Digital Angiography System Shimadzu Trinias Generator on 16 Dec 2021. The recall is Class II and its status is Ongoing. Recall number Z-0655-2022.

Why was it recalled?

Due to the inadequate adjusting criteria in installation, the system generator on two Digital Angiography Systems, the irradiated x-ray may exceed the x-ray radiation dose rate in fluoroscopic mode.

Which lots are affected?

Generator Model: D150GC-40 Serial Number Range - 3M99D44446001to LM99D44B8001 Serial Number/SMS ID: 41E58C765001/SMS20160146 41EFCD78B001/SMS20190007 41EFD3B9A001/SMS20200009 41F005CB8001/SMS20210266 41E58C766001/SMS20160150 41B247746001/SMS20140089 41E58C757001/SMSHP150024 41E58C769001/SMS20160151 41E58C777001/SMS20170121 41EFCD77C001/SMS20180143 41F005B8C001/SMS20190052 41EFCD79A001/SMS20190366 41EFCD79C001/SMS20200285 41EFC73A5001/SMS20200263 41EFCD7A6001/SMS20200267 41EFC73A9001/SMS20200443 41E5E23AA001/SMS20200369 41E58C773001/SMSHP170001 41E58C977001/SMS20170424 41EFFF79A001/SMS20190376 41EFFF79C001/SMS20200031 41EFD3B9C001/SMS20200066 41E58C76B001/SMS20170288 41E58C775001/SMS20170134 41E58C776001/SMS20170135 41F005B91001/SMS20190019 41B24774C001/SMSMA140084 41EFCD7AC001/#N/A

Where was it sold?

U.S.: CA, FL, GA, IL, IN, KY, LA, MI, MS, OH, PA, SC, TN, TX and WA O.U.S.: Not provided.

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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