Recall Z-2838-2018 ยท IYB Tube Mount, X-Ray, Diagnostic
Siemens Medical Solutions USA, Inc
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.
| Date | Jun 29, 2018 |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| Action | On 6/29/18, the firm emailed its four affected original equipment manufacturers (OEMs), alerting them to the potential malfunction of the ceiling stand's lifting column that could cause the arm to drop down during patient positioning. Manufacturers were asked to distribute an attached Safety Notice to affected customers. In addition, the firm urged manufacturers to order retrofit kits for all customers and to take any steps needed to ensure that customers install the kits. The kits are free of charge. Manufacturers were also asked to complete a response form and return to the firm. Affected |
| Quantity | 667 |
| Distribution | US Nationwide Distribution to accounts in IL, FL, and NY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.