Reported Apr 27, 2022 · Ongoing
Artis Q.zen biplane, Model Number 10848355
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 biplane, Model Number 10848355
- Lot codes and dates
- UDI4056869010038
- Serial Numbers
67 of 67 codes
123225123245123026123043123031123053123202123050123248123008123255123252123259123035123211123247123011123003123032123208123209123231123246123254123025123036123220123221123222123206123207123268123240123262123265123219123505123213123250123251123022123229123205123502123201123023123024123224123232123233123234123501123027123049123249123055123056123037123264123010
- Additional Serial Numbers as of 10/4/23123216 123239
- Amount recalled
- 69 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.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Siemens Medical Solutions USA, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.