Device product
3D V, model. no. 7042042 7042059 3070021 Product Usage: The ceiling stand is used to hold the X-ray tube and / or the detector and is moveable on a ceiling rail system in three axis. The tube and / or detector can be rotated above a horizontal and a vertical axle. The ceiling stand can be used within a stationary diagnostic X-ray system as well.
Z-2838-2018
Product summary
- Event
- Event 80735
- Status
- Terminated
- Classification
- Class II
- Quantity
- 667
- Official record key
device-enforcement:Z-2838-2018
Official wording
Reason: In rare cases of insufficient maintenance or high clinical workload, the first rope of the ceiling stand, which is designed to take the load, could break without triggering the safety lock and this could lead to overloading the safety rope which is not designed for continuous load and ongoing movement under load. This may lead to mechanical fatigue and cause the arm to drop down during patient positioning. Patients and users may be seriously injured.
Code information: 7042042 : S/N 1002 to 1787 7042059: S/N 1002 to 1921
Distribution pattern: US Nationwide Distribution to accounts in IL, FL, and NY.
Derived failure modes
-
Unknown
In rare cases of insufficient maintenance or high clinical workload, the first rope of the ceiling stand, which is designed to take the load, could break without triggering the safety lock and this could lead to overloading the safety rope which is not designed for continuous load and ongoing movement under load. This may lead to mechanical fatigue and cause the arm to drop down during patient positioning. Patients and users may be seriously injured.