Recall Z-3191-2018 ยท KPR System, X-Ray, Stationary
Swissray Medical
ddR Formula B X-ray System, Model ddR Formula B X-ray system used for imaging
| Date | Sep 18, 2018 (initiated Nov 18, 2016) |
| Status | Open, Classified |
| Reason | Potential for bucky (the part that holds the grid and is moveable to position the patient) moving unexpectedly. |
| Root cause | Device Design |
| Action | The firm, Swissray Medical, issued official communication to customers as a Action Notification Report/work Instructions on November 18 2016. The Work Instructions state the affected devices, the problem symptoms, causes of the problem, remedy, any tools required, and the step-by-step corrective actions. 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 ( |
| Quantity | 27 devices in US |
| Distribution | Worldwide Distribution: US (Nationwide) and to countries of: Austria, Dubai, China. Germany, Libya, Malaysia, Russia, and South Africa. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052943 | DDRFORMULA AND DDRFORMULA PLUS Swissray Medical AG, Dec 15, 2005 |