Class 2 Device Recall ddR Formula B xray system

• Date Initiated by Firm: November 18, 2016
• Date Posted: September 18, 2018
• Recall Status: Open, Classified
• Recall Number: Z-3191-2018
• Recall Event ID: 80981
• 510(K)Number: K052943
• Product Classification: System, x-ray, stationary - Product Code KPR
• Product: ddR Formula B X-ray System, Model ddR Formula B; ; X-ray system used for imaging
• Code Information: 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
• Recalling Firm/ Manufacturer: Swissray Medical; Hohenrainstrasse 61; Hochdorf Switzerland
• Manufacturer Reason for Recall: Potential for bucky (the part that holds the grid and is moveable to position the patient) moving unexpectedly.
• FDA Determined 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 (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.
• Quantity in Commerce: 27 devices in US
• Distribution: Worldwide Distribution: US (Nationwide) and to countries of: Austria, Dubai, China. Germany, Libya, Malaysia, Russia, and South Africa.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = KPR and Original Applicant = SWISSRAY MEDICAL AG