Reported Apr 27, 2022 · Ongoing
Artis zee floor, Model Number 10094135
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 floor, Model Number 10094135
- Lot codes and dates
- UDI4056869010045
- Serial Numbers
295 of 295 codes
138481137729124071138390135944137623135111135112124267124253137165124335124338124400137391137714124081135120137282135358137618137226135757136513137103137118137461135102136042138124138132135927137510138260138012138058137193135986135935135953138055124303135841138497135200135201135279124061135879135229136113135990138035138214137479138156124083137532137540136077
- Additional Serial Numbers as of 10/4/23
136450135352124201124089136548136568124015136607136586136555
- Amount recalled
- 305 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.
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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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