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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-1205-03
Recall Event ID 26581
510(K)Number K912470  
Product Classification Table, Radiographic, Non-Tilting, Powered - Product Code IZZ
Product Multidiagnost 97
Code Information The firm utilizes a site number specific to each unit: X1207, X1069, X0668, 76345, 17605, 17436, 6852, 6853, 13709, 13971, 6935, 13608, 13951, 6981, 6993, 35481, 86113, 38023, 41372, 62666, 62667, 38897, 37995, 59497, 62936, 62504, 62885, 62988, 62937, 74057, 38657, 38530, 38500, 74056, 59633, 45014, 45013, 47166, 40940
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
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 39
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.
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