Toshiba American Med Sys Inc Pinhole Collimator (NDCL709A) for Digital Gamma Cameras GCA-7100A series and CGA-7200A series. Regulation Number 21 CFR 892.1200, Class 2 device, . Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Pinhole Collimator (NDCL709A) for Digital Gamma Cameras GCA-7100A series and CGA-7200A series. Regulation Number 21 CFR 892.1200, Class 2 device, .
Brand
Toshiba American Med Sys Inc
Lot Codes / Batch Numbers
Various serial numbers.
Products Sold
Various serial numbers.
Toshiba American Med Sys Inc is recalling Pinhole Collimator (NDCL709A) for Digital Gamma Cameras GCA-7100A series and CGA-7200A series. R due to Pinhole collimator defective.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Pinhole collimator defective.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026