Device product
INFX-8000V Fluoroscopic X-Ray Systems; INFINIX CF-I/BP PLUS CARDIAC SYSTEM
Z-0844-2018
Product summary
- Event
- Event 79153
- Status
- Terminated
- Classification
- Class II
- Quantity
- 29 units
- Official record key
device-enforcement:Z-0844-2018
Official wording
Reason: 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.
Code information: Serial Numbers: UFD13X2015, UFD13X2016, UUC13Z2011, UEC1422013, UFD1442017, UFD1452018, AAA1642005, UUC1452012, UTC14Y2008, ACA1472001, ACA1492002, AAA1492001, AAA14X2002, A8A1532001, A9A1542001, AAA1542003, A9A1582002, ABB1627001, ACB1622003, A9A1662003, AAA1692006, A9A16X2004, A8B16Y2002, A7B16Y2001, ACB16Y2004, AAA1632004, AAA1712007, W4B1622031, W4B14Y2023
Distribution pattern: United States
Derived failure modes
-
Unknown
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.