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Terminated

Regius-IM. The Regius Image Manager for Centralized workflow and improved image quality software.

FDA Recall Z-1391-05 · Posted 2005-08-13

Recalling FirmKonica Medical Imaging, Inc.
Recall StatusTerminated
Product CodeLMA
Date Initiated2005-03-30
Date Terminated2005-08-31
Product Quantity60

Reason for Recall

One feature of the software on some of the devices which permits assembling three digital images into one image has occasionally had problems aligning the three images exactly.

Firm Action

The firm contacted all customers of the problem on 4/7/2005.

Root Cause

Other

Distribution Pattern

These units have been distributed to hospitals and clinics nationwide.

Official Source

View FDA Recall →

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

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