Reported Apr 27, 2022 · Ongoing
Artis zee biplane, Model Number 10094141
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 zee biplane, Model Number 10094141
- Lot codes and dates
- UDI4056869010069
- Serial Numbers
370 of 370 codes
153131153229154827155168154408153172153315153317153992154157154616155122155149153717154551153779153280153648155265153166154536154767154454155190154715153834154789154779153169154532153803131022153110131209153199154721154722153887154571154074154012155323153191153252154612153274153239153227153889154090153285153234153236154658154847154686153273153344154095153342
- Additional Serial Numbers as of 10/4/23154453 154094 131006
- Amount recalled
- 373 systems
This recall covers 18 products
The agency filed one notice per product. You are reading one of them; the other 17 are below.
5 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message "TUBE HOT, have a break". Several minutes later the system will block X-ray to prevent further damage and display the message "NO XRAY: TUBE TOO HOT".
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
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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