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U.S. Department of Health and Human Services

Class 2 Device Recall BABIX holder for DigitalDiagnost Xray system

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  Class 2 Device Recall BABIX holder for DigitalDiagnost Xray system see related information
Date Initiated by Firm September 09, 2010
Date Posted October 07, 2010
Recall Status1 Terminated 3 on July 22, 2011
Recall Number Z-0022-2011
Recall Event ID 56707
510(K)Number K982795  
Product Classification System, x-ray, stationary - Product Code KPR
Product The BABIX holder is an accessory used with the DigitalDiagnost X-ray system. It is used to hold the baby either in a secured or immobilized standing position in front of the X-ray detector during the examination.
Code Information Devices are identified as Site Number: 536043 
Recalling Firm/
Manufacturer		 Philips Medical Systems North America Co. Phillips
22100 Bothell Everett Hwy
Bothell WA 98021-8431
For Additional Information Contact Philips Healthcare Call Center
425-487-7602
Manufacturer Reason
for Recall		 Potential of broken strands in the main steel cable supporting the accessory holder used with BuckyDiagnost and DigitalDiagnost X-ray systems.
FDA Determined
Cause 2		 Equipment maintenance
Action Philips issued URGENT-Device Correction Notice letters dated September 9, 2010 to their consignees identifying the affected products and action to be taken by customers. The letter states that Babix holder used with Philips BuckyDiagnost and DigitalDiagnost X-Ray System - VS Wall Stand Risk of steel cable fracture in the support holder. The consignees are informed that there is a potential of broken strands at the main steel cable within the holder which cannot be recognized by the user. The firm will issue the Field Change Order (FCO) and the Service Engineer will replace the Babix holder. Consignees can call Philips Call Center at 800-722-9377, #5 (then follow prompts) and reference to FCO 70400038 for the BuckyDiagnost X-ray system and FCO 71200046 for the DigitalDiagnost X-ray system.
Quantity in Commerce 1 unit
Distribution Nationwide Distribution in the states of CA, GA, and TN.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KPR and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.
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