Date Initiated by Firm | September 09, 2010 |
Date Posted | October 07, 2010 |
Recall Status1 |
Terminated 3 on July 22, 2011 |
Recall Number | Z-0021-2011 |
Recall Event ID |
56707 |
510(K)Number | K945278 |
Product Classification |
System, x-ray, stationary - Product Code KPR
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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. |
Code Information |
Devices are identified as Site Numbers: 546607, 48682949, 554660, and 555738. |
Recalling Firm/ Manufacturer |
Philips Medical Systems North America Co. Phillips 22100 Bothell Everett Hwy Bothell WA 98021-8431
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For Additional Information Contact | Philips Healthcare Call Center 425-487-7602 |
Manufacturer Reason for Recall | Potential of broken strands in the main steel cable supporting the accessory holder used with BuckyDiagnost and DigitalDiagnost X-ray systems. |
FDA Determined Cause 2 | 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. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = KPR
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