—#94329

Product

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.

FDA product code: KPR — System, X-Ray, Stationary
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K945278
Affected lot / code info: Devices are identified as Site Numbers: 546607, 48682949, 554660, and 555738.

Why it was recalled

Potential of broken strands in the main steel cable supporting the accessory holder used with BuckyDiagnost and DigitalDiagnost X-ray systems.

Root cause (FDA determination)

Equipment maintenance

Action the firm took

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.

Recalling firm

Firm: Philips Medical Systems North America Co. Phillips
Address: 22100 Bothell Everett Hwy, Bothell, Washington 98021-8431

Distribution

Distribution pattern: Nationwide Distribution in the states of CA, GA, and TN.

Timeline

Recall initiated: 2010-09-09
Posted by FDA: 2010-10-07
Terminated: 2011-07-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #94329. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.