Class 2 Device Recall

• Date Initiated by Firm: February 20, 2002
• Date Posted: September 12, 2003
• Recall Status: Terminated 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: 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