Reported May 3, 2023 · Ongoing
ARTIS one with a hybrid cable- An angiography system developed for diagnostic imaging and interventional procedures.…
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 one with a hybrid cable- An angiography system developed for diagnostic imaging and interventional procedures
- Material Number10848600
- Lot codes and dates
- UDI-DI04056869009964
- US Serial Numbers82587 82570 82577 82562 OUS Serial Numbers;
141 of 141 codes
826018262982663826958243282542826198263182433825748260682610826558267582676827008270582706823268232782438824548247782484824948250082502825068250882512825158251682517825198252082525825268252982530825318253382536825378253982540825498256182568825768258182582825858258682593825948259982607826088260982616
- Amount recalled
- 4 units US
Where it was sold
Why it was recalled
Examination room monitor connected with the hybrid cable may have a display issue and no image function is available
This product could cause temporary or reversible health problems — stop using it.
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