FDA Device Recall Z-0022-2011: Philips Medical Systems North America Co. Phillips

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0022-2011.

Recall Res Number

Z-0022-2011

Recalling Firm / Manufacturer

Philips Medical Systems North America Co. Phillips

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

1 unit

Product Description 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.

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 Number: 536043

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Medical Device Recall: Z-0022-2011

Recall Parameters & Description

Related Establishments / Registrations

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