Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Pinhole Collimator (NDCL709A) for Digital Gamma Cameras GCA-7100A series and CGA-7200A series. Regulation Number 21 CFR 892.1200, Class 2 device, .

FDA Recall Z-1059-04 · Posted 2004-07-20

Recalling FirmToshiba American Med Sys Inc
Recall StatusTerminated
Product CodeKPS
Date Initiated2004-05-31
Date Terminated2005-07-13
Product Quantity40

Reason for Recall

Pinhole collimator defective.

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K931297GCA-7200AToshiba America Medical Systems, In.C · 1993-07-27

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑