Z-2838-2018 Class II Terminated
FDA device recall Z-2838-2018 was initiated by Siemens Medical Solutions USA, Inc on Jun 29, 2018 and is designated Class II. 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… The recall status is terminated (terminated Oct 4, 2019). Affected quantity: 667.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 29, 2018
- Initiation Date
- Jun 29, 2018
- Termination Date
- Oct 4, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 667
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.
Distribution Pattern
US Nationwide Distribution to accounts in IL, FL, and NY.
Code Information
7042042 : S/N 1002 to 1787 7042059: S/N 1002 to 1921
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2838-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026