Recall Z-3248-2018 ยท KPR System, X-Ray, Stationary
Swissray Medical
ddR Formula B X-ray System, ddR Formula B Product Usage: X-ray system used for imaging
| Date | Sep 25, 2018 (initiated Aug 9, 2016) |
| Status | Open, Classified |
| Reason | Possible injury due to movement of the arm, calibration loss and communication loss. |
| Root cause | Device Design |
| Action | November 2016, Swissray Medical issued official communication to customers as a Action Notification Report. The manufacturer, Swissray Medical AG, distributed the Work Instructions for the FCO and the Action Notification Report Form to all distributors and service entities who would be performing corrective actions in the field. The Swissray Field Engineer then presented the Report to the customer (end user facility) and communicated with the customer in-person while performing the corrective action on-site. When corrective actions were completed, both the customer and service personnel then s |
| Quantity | 26 units |
| Distribution | US Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052943 | DDRFORMULA AND DDRFORMULA PLUS Swissray Medical AG, Dec 15, 2005 |