FDA Medical Device Recalls (openFDA)
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 number
- Z-1059-04
- Recalling firm
- Toshiba American Med Sys Inc
- Product
- Pinhole Collimator (NDCL709A) for Digital Gamma Cameras GCA-7100A series and CGA-7200A series. Regulation Number 21 CFR 892.1200, Class 2 device, .
- Status
- Terminated
- Initiated
- 2004-05-31
- Posted
- 2004-07-20
- Terminated
- 2005-07-13
- Reason
- Pinhole collimator defective.
- Root 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
- 40
- Distribution
- Nationwide.
- Lot, serial or model codes
- Various serial numbers.
- 510(k) numbers
- K931297
- PMA numbers
- not on file
- Product code
- KPS
- Firm FEI
- 2020563
- Firm city
- Tustin
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28