Reported Apr 27, 2022 · Ongoing
Artis zeego, Model Number 10280959
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, Model Number 10280959
- Lot codes and dates
- UDI4056869010083
- Serial Numbers
169 of 169 codes
160851160879161046160395160484161041160351161218160999161032161204161226160838160449160852160463160411160106160134160136160953160347160913161206160961160312160877161008160488160997160864160448160937160965160427160455160884160486161236160435160451160823160951160384160431160100160916160814160872160391160470160321160376160915160447161021160481160401160119160403
- Additional Serial Numbers as of 10/4/23
160501160519160406160900160850160959160461160903126206160905160930160967160925160469
- Amount recalled
- 183 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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