Reported May 10, 2023 · Ongoing
ARTIS pheno systems with a Siemens Healthineers table or Trumpf/MAQUET table (OEM)- Angiography systems developed for…
Siemens Medical Solutions USA, Inc.
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: Siemens Medical Solutions USA, Inc · 40 Liberty Blvd · Malvern, PA · 19355-1418
Is this the product you have?
- ARTIS pheno systems with a Siemens Healthineers table or Trumpf/MAQUET table (OEM)- Angiography systems developed for single and biplane diagnostic imaging and interventional procedures
- Model10849000
- Lot codes and dates
- UDI04056869046877
- S/NSerial #
141 of 141 codes
164140164159164138164332164331164033164287164282164210164184164183164311164142164312164071164328164034164391164318164244164306164155164340164189164277164173164292164231164095164057164055164054164329164072164190164048164025164026164027164338164094164241164326164267164186164068164121164157164019164152164161164013164069164213164073164293164263164298164060164083
- Amount recalled
- 141 units US
Where it was sold
- Nationwide
Why it was recalled
If, during the procedure, X-ray has been released and a reference image has been stored, the following issue may occur: If "Adjust C-arm to Ref" is activated when the C-Arm is positioned outside of the working range the C-Arm will reach the target position with an inaccuracy of 5-10 mm. As a result, the message Endposition reached will be displayed .Leading to unintended direction of the movement causing crushing of a patient, staff member, operator, or equipmen Live images may not match the previously stored reference images. Overlay images may be shown inaccurate on anatomy (e.g., DSA Roadmap workflow does not match real anatomy). This may cause e.g., a vessel perforation in DSA roadmap.
This product could cause temporary or reversible health problems — stop using it.
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