Z-1059-04

Pinhole Collimator (NDCL709A) for Digital Gamma Cameras GCA-7100A series and CGA-7200A series. Regulation...

Name: Z-1059-04 Pinhole Collimator (NDCL709A) for Digital Gamma Cameras GCA-7100A series and CGA-7200A series. Regulation...
Creator: Toshiba American Med Sys Inc
Published: 2004-05-31
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2004-05-31 / Terminated

FDA source

Toshiba American Med Sys Inc began a recall of Pinhole Collimator (NDCL709A) for Digital Gamma Cameras GCA-7100A series and CGA-7200A series. Regulation Number 21 CFR 892.1200, Class 2 device on 2004-05-31. The reason FDA records is "Pinhole collimator defective". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1059-04
Status: Terminated
Initiated: 2004-05-31
Posted: 2004-07-20
Terminated: 2005-07-13
Recalling firm: Canon Medical Systems USA, 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, .
Product code: KPS System, Tomography, Computed, Emission
Reason for recall: Pinhole collimator defective.
FDA 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 in commerce: 40
Distribution: Nationwide.
Product codes and lots: Various serial numbers.

Product code KPS

K931297Class IIGca-7200AToshiba America Medical Systems, In.C / cleared 1993-07-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)