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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmSeptember 27, 2002
Date PostedFebruary 01, 2003
Recall Status1 Terminated 3 on January 12, 2005
Recall NumberZ-0526-03
Recall Event ID 25248
510(K)NumberK953910 
Product Classification System, X-Ray, Mobile - Product Code IZL
ProductPhilips BV300 Mobile X-Ray System
Code Information Part numbers 9896 000 06801 and 9806 000 06802 with serial numbers: DBXXXX - all DBXXXX - all DDXXXX - all DEXXXX - all DG0001-DG0129 DH0001-DH0033 DJ0001 - DJ0152 DK0001 - DK 0076
FEI Number 1000524572
Recalling Firm/
Manufacturer		 Philips Medical Systems
22100 Bothell Everett Highway
Bothell WA 98041
For Additional Information ContactSarah Baxter
425-487-7665
Manufacturer Reason
for Recall		The C-bow support can bend and break allowing C-arm to fall from support
FDA Determined
Cause 2		Other
ActionThe firm issued a letter dated 9/27/02 to their customers. The letter advised of the problem and that a service representative will visit to inspect unit and correct.
Quantity in Commerce229 devices
DistributionThe firm distributed to hospitals, x-ray centers and medical centers throughout the U.S.
Total Product Life CycleTPLC Device Report
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.
510(K) Database510(K)s with Product Code = IZL
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