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Terminated

Calculator/ Data Processing Module for Clinical Use

FDA Recall Z-1240-03 · Posted 2003-10-15

Recalling FirmMisys Healthcare Systems
Recall StatusTerminated
Product CodeJQP
Date Initiated2003-07-23
Date Terminated2004-04-23
Product Quantity466

Reason for Recall

Software Defect. Data used in the diagnosis and or treatment of a patient's illness are missing from the patient result report.

Firm Action

Notification to all affected customers was sent by fax on 07/23/03 under PSN-03-L35, with the problem description, effective workaround and estimated release of coding modifications to the software version impacted.

Root Cause

Other

Distribution Pattern

Nationwide

Official Source

View FDA Recall →

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

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