Reported Nov 10, 2021 · Ongoing
Artis zeego, Fluoroscopic X-Ray System Models: 10280959,10502505, 10848283 in combination with the following…
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 zeego
- Fluoroscopic X-Ray System Models10280959,10502505, 10848283 in combination with the following workplace/system
- application software models
Product/Model #: syngo X Workplace10281061 syngo X Workplace10281299 syngo X Workplace10502522 Syngo Application Software10848815
- Lot codes and dates
- Artis zeego systems with Artis patient table and AppSW VD20C/VD20N
- Amount recalled
- 43 US
Where it was sold
- Nationwide
Why it was recalled
Software error, the software can produce an incorrect interpretation of the table rotation if the table has been rotated by more than 4degrees in either direction. This can cause the 3D image reconstruction to be shown rotated by up to 5 degrees relative to the patient and to be used inappropriately by the system and result in incorrect treatment of the patient
This product could cause temporary or reversible health problems — stop using it.
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