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Terminated

Radiomat Lightweight Cassettes

FDA Recall Z-1404-05 · Posted 2005-08-25

Recalling FirmAGFA Corp.
Recall StatusTerminated
Product CodeIXA
Date Initiated2005-01-26
Date Terminated2006-06-20
Product Quantity9055 units

Reason for Recall

Users of these cassettes may detect poor film to screen contact and unsatisfactory sharpness of radiographic images.

Firm Action

Consignees were notified by letter on/about 07/29/2005.

Root Cause

Other

Distribution Pattern

Nationwide, Canada

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K023020AGFA MAMORAY MAMMOGRAPHIC CASSETTE, AGFA METAL-BODIED CAWO CASSETTE, AGFA CURIX AND LIGHTWEIGHT CASSETTEAgfa Corp. · 2002-09-26

Official Source

View FDA Recall →

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

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