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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 FirmFebruary 20, 2002
Date PostedSeptember 12, 2003
Recall Status1 Terminated 3 on April 11, 2005
Recall NumberZ-1203-03
Recall Event ID 26581
510(K)NumberK912470 
Product Classification Table, Radiographic, Non-Tilting, Powered - Product Code IZZ
ProductDiagnost 94
Code Information The firm utilizes a site number specific to each unit: 26018, 62634, 62635, 38507
Recalling Firm/
Manufacturer		 Philips Medical Systems
22100 Bothell Everett Highway
Bothell WA 98041
For Additional Information Contact
425-487-7000
Manufacturer Reason
for Recall		Spontaneous movement of table without input from an operator
FDA Determined
Cause 2		Other
ActionOn 2/20/02 the firm issued Field Change Order to their field personnel, instructing them to visit each site and upgrade each unit.
Quantity in Commerce4
DistributionThe firm distributed units to hospitals and medical centers located throughout the US.
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 = IZZ
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