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U.S. Department of Health and Human Services

Class 2 Device Recall ddR Formula B xray system

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  Class 2 Device Recall ddR Formula B xray system see related information
Date Initiated by Firm August 09, 2016
Date Posted September 25, 2018
Recall Status1 Open3, Classified
Recall Number Z-3248-2018
Recall Event ID 81045
510(K)Number K052943  
Product Classification System, x-ray, stationary - Product Code KPR
Product ddR Formula B X-ray System, ddR Formula B

Product Usage:
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, 1702001, 1702002, 1702003 & 1702004
Recalling Firm/
Swissray Medical
Hohenrainstrasse 61
Hochdorf Switzerland
Manufacturer Reason
for Recall
Possible injury due to movement of the arm, calibration loss and communication loss.
FDA Determined
Cause 2
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 sign the Report to confirm that the customer was informed about the corrective action and that corrective action was completed.
Quantity in Commerce 26 units
Distribution US Nationwide
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