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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm February 20, 2002
Date Posted September 12, 2003
Recall Status1 Terminated 3 on April 11, 2005
Recall Number Z-1203-03
Recall Event ID 26581
510(K)Number K912470  
Product Classification Table, Radiographic, Non-Tilting, Powered - Product Code IZZ
Product Diagnost 94
Code Information The firm utilizes a site number specific to each unit: 26018, 62634, 62635, 38507
Recalling Firm/
Philips Medical Systems
22100 Bothell Everett Highway
Bothell WA 98041
For Additional Information Contact
Manufacturer Reason
for Recall
Spontaneous movement of table without input from an operator
FDA Determined
Cause 2
Action On 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 Commerce 4
Distribution The firm distributed units to hospitals and medical centers located throughout the US.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = IZZ and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.