The BABIX holder is an accessory used with the DigitalDiagnost X-ray system. It is used to hold the baby either in a sec
FDA device recall Z-0022-2011 · posted 2010-10-07 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems North America Co. Phillips
- 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 taken
- 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.
- Root cause
- Equipment maintenance
- Status
- Terminated
- Product code
- KPR
- Quantity affected
- 1 unit
- Distribution
- Nationwide Distribution in the states of CA, GA, and TN.
- Date initiated
- 2010-09-09
- Date posted
- 2010-10-07
- Date terminated
- 2011-07-22
- Location
- Bothell, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PHILIPS BUCKY VISION (K982795) | Philips Medical Systems, Inc. | 1998-11-24 |