Recall Z-2838-2018— Siemens Medical Solutions USA, Inc
Class II · Terminated
Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2018-06-29, terminated 2019-10-04. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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..
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-06-29
- Terminated
- 2019-10-04
- Firm location
- Malvern, PA, United States
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.