FDAFDA · Food and drugs·Recall number Z-0843-2018
INFX-8000C Fluoroscopic X-Ray Systems
Published March 14, 2018 · Recall initiated: December 29, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Toshiba American Medical Systems Inc
- Distributor
- United States
- Lot
- Serial Numbers: U6A1472001, UWB1422001, U6C13Y2007, A3A14Z2001, A6B1532003, A1B1552001, A6B1582004, A9B1622002, A9A1592001, A5C1622001, A6B1682005, A6B16X2006, A5C16Y2002, A1D1752002, AFA1662001, A9B1722003, A6B1742007, A6A1492002, A4B1472002
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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