Reported Apr 27, 2022 · Ongoing
Artis Q floor, Model Number 10848280
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 floor, Model Number 10848280
- Lot codes and dates
- UDI4056869009971
- Serial Numbers
64 of 64 codes
103221103217103218103345103409103340103439104007103302103232104016104005103391103404104027132002103334103354103359103030103335104012103220103013103384103035104029104020103039103050103365103279104025103285103286103207103222103230103295103310103430103432104047103001103239103353104013103444132502132500103048103315103263103356132000103028103241103293103388103389
- Additional Serial Numbers as of 10/4/23
160501160519160406160900160850160959160461103053103040160903126206160905160930160967160925160469
- Amount recalled
- 80 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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