Recall Z-1083-2024 ยท IZL System, X-Ray, Mobile
SEDECAL SA
MobileDiagnost wDR, Model numbers 712001, 712002, 712004, 712006, and 712007
| Date | Feb 14, 2024 (initiated Oct 14, 2021) |
| Status | Open, Classified |
| Reason | While cleaning or disinfecting the system, if the process is not followed as described in the manual and excessive liquid is used or sprayed directly on the system, it could cause a short circuit of the fine positioning control button. This would result in the system moving on its own in a very slow speed forward circular motion. |
| Root cause | Use error |
| Action | The distributor in the U.S., Philips, issued letters to consignees dated 05-October-2021 and flagged "IMPORTANT PRODUCT NOTICE" via certified mail on 10/14/2021. The letter explained the problem and under what circumstances it can occur, how to identify whether the consignee has the affected product, and the actions that can be taken to minimize the effect of the problem. The consignee is to: (1) Circulate this notice to all users of the device so that they are aware of the issues; (2) Attach this notice as an addendum to the MobileDiagnost wDR IFU for ease of reference; (3) If unintended mo |
| Quantity | 851 devices |
| Distribution | US Nationwide distribution. There was government distribution but no military distribution. |
| FDA record | Open on fda.gov |