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

Digital Angiography System Bransist safire Generator recalled

Shimadzu Medical Systems is recalling Digital Angiography System Bransist safire 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 - 0161Q81103 to 3M99D3A55001 Specific Generator Serial Number/SMS ID: 3M99D3A24001/SMS20120038 3M99D3A4B001/SMS20140084 3M99D3A55001/SMS20150030 0161Q83701/SMS20080542 0161Q82204/SMS20080045 0161Q82302/SMS20080043 0161Q82304/SMS20080046 0261Q80901/SMS20100011 3M7A1600B001/SMS20080286 3M99D2622001/SMSMA110079 0161Q84501/SMS20090038 3M7A1600C001/SMS20200285 3M7A16A1A001/SMSMA110013 3M99D3A1C001/SMS20110202 0161Q84103/SMS20090099 0161Q83603/SMS20080505 0161Q83702/SMS20080580 0161Q83703/SMS20080581

Quantity recalled18

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-0654-2022
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 Bransist safire 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

Questions about this recall

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 - 0161Q81103 to 3M99D3A55001 Specific Generator Serial Number/SMS ID: 3M99D3A24001/SMS20120038 3M99D3A4B001/SMS20140084 3M99D3A55001/SMS20150030 0161Q83701/SMS20080542 0161Q82204/SMS20080045 0161Q82302/SMS20080043 0161Q82304/SMS20080046 0261Q80901/SMS20100011 3M7A1600B001/SMS20080286 3M99D2622001/SMSMA110079 0161Q84501/SMS20090038 3M7A1600C001/SMS20200285 3M7A16A1A001/SMSMA110013 3M99D3A1C001/SMS20110202 0161Q84103/SMS20090099 0161Q83603/SMS20080505 0161Q83702/SMS20080580 0161Q83703/SMS20080581

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 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.

Other products in this recall event

1 other product · FDA event 89253

Reported	Class	Recall	Company	Reason	Where
9 Mar 2022	CLASS II	Digital Angiography System Shimadzu Trinias Generator recalled	Shimadzu Medical Systems	Other	15 states

More recalls from Shimadzu Medical Systems

All 25

Reported	Class	Recall	Company	Reason	Where
13 Apr 2022Device	CLASS II	Model: X-ray R/F System FLUOROspeed X1 recalled	Shimadzu Medical Systems	Other	37 states
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13 Apr 2022Device	CLASS II	Model: X-ray TV Sysstem Sonialvision safire17 recalled	Shimadzu Medical Systems	Other	37 states
9 Mar 2022Device	CLASS II	Digital Angiography System Shimadzu Trinias Generator recalled	Shimadzu Medical Systems	Other	15 states
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