Medical Device Recall: Z-0021-2011

FDA Recalls dataset · Firm: Philips Medical Systems North America Co. Phillips · Status: Terminated

Recall Action Class: N/A Date Initiated: 2010-09-09 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0021-2011.

Recall Res Number
Z-0021-2011
FEI Number
1000524572
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2010-09-09
Date Posted
2010-10-07
Date Terminated
2011-07-22
Product Code
KPR
Event Number
56707
Product Quantity
4 units
Product Description The 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.
Reason for Recall Potential of broken strands in the main steel cable supporting the accessory holder used with BuckyDiagnost and DigitalDiagnost X-ray systems.
Action Details 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.
Distribution Pattern Nationwide Distribution in the states of CA, GA, and TN.
Code Information / Serial Numbers Devices are identified as Site Numbers: 546607, 48682949, 554660, and 555738.

Related Establishments / Registrations

Public Record Disclaimer

This page represents an index of public-record FDA device recalls. It does not imply current safety or compliance status of the product. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Refer to official government sources for primary safety alerts.

Account Required Full available specs will require a free AvaSpecs account.