Class 3 Device Recall

• Date Initiated by Firm: May 31, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated on July 13, 2005
• Recall Number: Z-1059-04
• Recall Event ID: 29296
• 510(K)Number: K931297
• Product Classification: System, Tomography, Computed, Emission - Product Code KPS
• Product: Pinhole Collimator (NDCL709A) for Digital Gamma Cameras GCA-7100A series and CGA-7200A series. Regulation Number 21 CFR 892.1200, Class 2 device, .
• Code Information: Various serial numbers.
• FEI Number: 2020563
• Recalling Firm/ Manufacturer: Toshiba American Med Sys Inc; 2441 Michelle Dr; Tustin CA 92781
• For Additional Information Contact: Paul Biggins; 714-730-5000
• Manufacturer Reason for Recall: Pinhole collimator defective.
• FDA Determined Cause: Other
• Action: Firm will be inspecting and replacing defective collimators, in addition, an advisory letter will be sent to all sites to alert to the inspection and replacement. Recall began May 31, 2004.
• Quantity in Commerce: 40
• Distribution: Nationwide.
• 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 = KPS