ddR Formula B X-ray System, Model ddR Formula B X-ray system used for imaging
- Recall Initiated
- November 18, 2016
- Posted
- September 18, 2018
- Recall Number
- Z-3191-2018
- Quantity
- 27 devices in US
Reason for Recall
Potential for bucky (the part that holds the grid and is moveable to position the patient) moving unexpectedly.
Distribution
Worldwide Distribution: US (Nationwide) and to countries of: Austria, Dubai, China. Germany, Libya, Malaysia, Russia, and South Africa.
Lot / Code Info
Serial Numbers within U.S.A commerce - 1302002, 1302003, 1302005, 1302009, 1302011, 1402001, 1402002, 1402006, 1402007, 1402008, 1402009, 1402011, 1402012, 1402015, 1502001, 1502002, 1502004, 1502005, 1502006, 1502007, 1602001, 1602002, 1602003, 1602005, 1602006, 1602007 & 1602008 Serial Numbers Outside of U.S.A commerce - 1402005, 1402017, 1502009, 1502010, 1502011, 1302004, 1302006, 1302007, 1302008, 1302010, 1402003, 1402004, 1402010, 1402013, 1402014, 1402016, 1502008 & 1602004
Root Cause
Device Design
Action Taken
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 (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. The Report Form states the title and unique designation of the corrective action, whether it was mandatory by the manufacturer or was an optional product improvement, and the unique document ID number of the Work Instructions for the FCO. The customers were instructed to Complete the FCO Action Notification Report and send to: Swissray Medical AG expert Center Turbistrasse 25-27 CH-6280 Hochdorf Switzerland Or scan and email to service@swissray.com with FCO in the subject line. If you have any questions, contact QA/RA Coordinator at 908-372-6408 or email: Deniz.Kortan@swissray.com.