Reported Apr 27, 2022 · Ongoing
Artis zee ceiling, Model Number 10094137
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 ceiling, Model Number 10094137
- Lot codes and dates
- UDI4056869010052
- Serial Numbers
683 of 683 codes
146669146877146996146663147100146286146292146410146676148281148299147155147678146406146407146411146166147762146121147885146710125115125276125262146945125253125213125238125245147189147190146679150011146766148429125265146232147573148454147996146408146409146728148498147889146335148404146659148499148235147909147833147847147888146898148402148333150002147273125105
- Additional Serial Numbers as of 10/4/23
146257147046146976147030146242147815147174147216147749147172147119148491147103147372125002147094147515146780146960147157147552147165146829147657147235147210
- Amount recalled
- 709 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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