Z-0021-2011

The BABIX holder is an accessory used with the BuckyDiagnost X-ray system. It is used to hold the baby either...

Name: Z-0021-2011 The BABIX holder is an accessory used with the BuckyDiagnost X-ray system. It is used to hold the baby either...
Creator: Philips Medical Systems North America Co. Phillips
Published: 2010-09-09
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2010-09-09 / Terminated / root cause: manufacturing process

FDA source

Philips Medical Systems North America Co. Phillips began a recall of 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... on 2010-09-09. The reason FDA records is "Potential of broken strands in the main steel cable supporting the accessory holder used with BuckyDiagnost and DigitalDiagnost X-ray systems". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0021-2011
Status: Terminated
Initiated: 2010-09-09
Posted: 2010-10-07
Terminated: 2011-07-22
Recalling firm: Philips North America LLC
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.
Product code: KPR System, X-Ray, Stationary
Reason for recall: Potential of broken strands in the main steel cable supporting the accessory holder used with BuckyDiagnost and DigitalDiagnost X-ray systems.
Root cause tag: manufacturing process
FDA root cause: 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: 4 units
Distribution: Nationwide Distribution in the states of CA, GA, and TN.
Product codes and lots: Devices are identified as Site Numbers: 546607, 48682949, 554660, and 555738.

Product code KPR

K945278Class IIPhilips Bucky Diagnost FamilyPhilips Medical Systems North America, Inc. / cleared 1994-12-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)