Reported Apr 27, 2022 · Ongoing
Artis Q.zen ceiling, Model Number 10848354
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 Q.zen ceiling, Model Number 10848354
- Lot codes and dates
- UDI4056869010021
- Serial Numbers
80 of 80 codes
111160111162111163111137111502111139111174111185111503111005111002111145111176111510111155111179111140111507111122111168111170111173111512111141111508111521111133111003111111111103111101111011111182111184111143111150111164111183111504111149111109111151111129111121111130111517111513111017111010111115111116111117111119111104111148111127111175111506111112111131
- Additional Serial Numbers as of 10/4/23111125
- Amount recalled
- 81 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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