Pinhole Collimator (NDCL709A) for Digital Gamma Cameras GCA-7100A series and CGA-7200A series. Regulation Number 21 CFR 892.1200, Class 2 device, .
- Company
- Toshiba American Med Sys Inc
- Recall Initiated
- May 31, 2004
- Posted
- July 20, 2004
- Terminated
- July 13, 2005
- Recall Number
- Z-1059-04
- Quantity
- 40
- Firm Location
- Tustin, CA
Reason for Recall
Pinhole collimator defective.
Distribution
Nationwide.
Lot / Code Info
Various serial numbers.
Root Cause
Other
Action Taken
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.
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