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U.S. Department of Health and Human Services

Class 2 Device Recall BABIX Holder for BuckyDiagnost Xray system

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 Class 2 Device Recall BABIX Holder for BuckyDiagnost Xray systemsee related information
Date Initiated by FirmSeptember 09, 2010
Date PostedOctober 07, 2010
Recall Status1 Terminated 3 on July 22, 2011
Recall NumberZ-0021-2011
Recall Event ID 56707
510(K)NumberK945278 
Product Classification System, x-ray, stationary - Product Code KPR
ProductThe BABIX holder is an accessory used with the BuckyDiagnost 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 Numbers: 546607, 48682949, 554660, and 555738. 
Recalling Firm/
Manufacturer		 Philips Medical Systems North America Co. Phillips
22100 Bothell Everett Hwy
Bothell WA 98021-8431
For Additional Information ContactPhilips 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
ActionPhilips 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 Commerce4 units
DistributionNationwide Distribution in the states of CA, GA, and TN.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = KPR
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