ddR Formula B X-ray System, ddR Formula B Product Usage: X-ray system used for imaging
Recall
- Recall Number
- Z-3248-2018
- Event Number
- 81045
- Firm
- Swissray Medical Hohenrainstrasse 61 Hochdorf Switzerland
- FEI Number
- 1000469975
- Product Code
- KPR
- Status
- Open, Classified
- Root Cause
- Device Design
- Initiated
- August 9, 2016
- Posted
- September 25, 2018
Description
ddR Formula B X-ray System, ddR Formula B Product Usage: X-ray system used for imaging
Possible injury due to movement of the arm, calibration loss and communication loss.
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 sign the Report to confirm that the customer was informed about the corrective action and that corrective action was completed.
US Nationwide
26 units