Reported Dec 16, 2020 · Ongoing
Bransist Safire, Digital Angiography System containing a MS-200 Ceiling Suspended C-arm Support - Product Usage:…
Shimadzu Medical Systems
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Shimadzu Medical Systems · 20101 S Vermont Ave · Torrance, CA · 90502-1328
Is this the product you have?
- Bransist Safire, Digital Angiography System containing a MS-200 Ceiling
- Suspended C-arm Support - Product Usagedesigned to provide fluoroscopic images of the patient during diagnostic surgical and interventional angiography and cardiology procedures
- Lot codes and dates
- Serial Numbers
40AD58C5500140AD58C4B00140AD58C2400140AD5852200140AD58C1C001101X968101091X955901
- Serial Numbers
- Amount recalled
- 7 units
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
The firm has identified a problem with the control software for the celling arm of the X-Ray System . This software issue could cause the ceiling arm of the device to move after the operator has released the movement lever. This could result in possible collision or harm to the patient or system operator.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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