Recall Z-1460-2014 ยท IZZ Table, Radiographic, Non-Tilting, Powered
Siemens Medical Solutions USA, Inc
AXIOM Vertix MD Trauma systems radiographic X-ray
| Date | Apr 16, 2014 (initiated Mar 5, 2014) |
| Status | Terminated |
| Reason | There is a potential issue and possible hazard to patients when using the AXIOM Vertix MD Trauma systems. In rare cases, steel ropes inside the lift column of the system can be defective without triggering the safety lock, which can result in the U-arm dropping down unexpectedly during movement in vertical direction, potentially causing serious injury. |
| Root cause | Component design/selection |
| Action | Siemens sent a Safety Advisory Notice dated March 5, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were advised as a first check it is strongly recommended for the users to check whether metallic dust or rubbed off parts of metal are visible underneath the lifting column or around the system. If this is the case, it is strongly recommended to immediately stop using the Vertix MD Trauma system and call the local Siemens service. To avoid any risk until the implementation of the modification mentioned |
| Quantity | 2 |
| Distribution | US Distribution including MO and OH. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K971452 | MULTIX TOP/PRO RADIOGRAPHIC X-RAY TABLE Siemens Medical Solutions USA, Inc., May 14, 1997 |