Reported Mar 14, 2018 · Terminated
INFX-8000C Fluoroscopic X-Ray Systems
Toshiba American Medical Systems 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: Toshiba American Medical Systems Inc · PO Box 2068 · Tustin, CA · 92780-7047
Is this the product you have?
- INFX-8000C Fluoroscopic X-Ray Systems
- Lot codes and dates
- Serial Numbers
U6A1472001UWB1422001U6C13Y2007A3A14Z2001A6B1532003A1B1552001A6B1582004A9B1622002A9A1592001A5C1622001A6B1682005A6B16X2006A5C16Y2002A1D1752002AFA1662001A9B1722003A6B1742007A6A1492002A4B1472002
- Serial Numbers
- Amount recalled
- 19 units
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Why it was recalled
During an examination a device error occurred and the ceiling drive operation was disabled. It was found that the fastening bolts of the driving portion of the ceiling drive loosened cause the error.
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.
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