Reported Apr 27, 2022 · Ongoing
Artis Q biplane, Model Number 10848282
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 biplane, Model Number 10848282
- Lot codes and dates
- UDI4056869009995
- Serial Numbers
262 of 262 codes
134007121314134008121396121590121665121564122025121627121185121430121406121336122012121471121195121467121612122022121530121089121094134004121169121006122021122028121013121040121501121368121526121208121548121515121445121446121623121082121459121011122037121039121521121371122005121374121204121614121305121536121053121054121422121014121112121325121357121621121167
- Additional Serial Numbers as of 10/4/23134502 121340 121461 121051 121179 121016 121022
- Amount recalled
- 269 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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