Recall Z-0697-2019 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Swissray Medical AG
ddRCombi Plus FP, Model Number 8.2000.0070.0 (US Version), 8.2000.0060.0 (Europe Version) The ddRCombi Plus FP is a fully digital, multifunctional X-ray system that allows the direct digitization of X-ray information without use of cassettes or other media. It can perform all applications in orthopedics and trauma as well as pulmonary imaging.
| Date | Jan 8, 2019 (initiated Nov 14, 2018) |
| Status | Terminated |
| Reason | A component of the device was recalled by a supplier. In rare cases of inadequate maintenance or very high clinical workload, the first steel wire rope of the lifting column, which is designed to take the load, can break without triggering the safety lock. This can lead to overloading of the safety cable, which is not designed to permanently carry the load of the lifting column or continuously move under load. This could cause material fatigue and cause the arm to drop unexpectedly during patient positioning. If the arm drops unexpectedly, patients and users may be seriously injured. |
| Root cause | Component design/selection |
| Action | A component of the device was recalled by a supplier (Siemens AG/Siemens Healthcare GmbH), as a result, Swissray Medical AG, sent an "Important Warning / Important Safety Notice" letters dated 11/14/18 to its customers. The letter described the product, problem and actions to be taken. The firm stated safety related retrofits are available for installation to eliminate risk to patients and users.The retrofit aims to completely correct the problem. The customers were instructed to do the following: To mitigate risk to patients and users until the retrofit modification is implemented, users are |
| Quantity | 3 |
| Distribution | Worldwide distribution: US distribution to states of: IL and MA and countries of: Czech Republic, Germany, Poland and Peru. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050718 | DDRCOMBI TRAUMA Swissray International, Inc., May 26, 2005 |