Reported Jul 31, 2019 · Terminated
AXIOM Artis dBC, Model Number 7728392
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?
- AXIOM Artis dBC, Model Number 7728392
- Lot codes and dates
- Serial Numbers
4412544151441014424644185442624426344199441054408444080440724424344198441714427544215442554408144242442654418944289441454406044144441844428644223440684419344244442014425144229443044415244136442544427744279442684420644278442594426044168442674411044218441654427144135
- Serial Numbers
- Amount recalled
- 53
This recall covers 23 products
The agency filed one notice per product. You are reading one of them; the other 22 are below.
10 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue occurs sporadically; however, it may occur during an on-going procedure.
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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