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Terminated

Calculator/Data Processing Module for Clinical Use

FDA Recall Z-0007-04 · Posted 2004-07-20

Recalling FirmMisys Healthcare Systems
Recall StatusTerminated
Product CodeJQP
Date Initiated2003-08-12
Date Terminated2004-03-15
Product Quantity479

Reason for Recall

Software defect. Clinical Laboratory results failing quality assurance were filed directly to a patient's chart without review.

Firm Action

Product Safety Notice, PSN-03-L37 was issued to all affected clients by facsmile. The notice provides product users with a description of the problem, an effective workaround, and the estimated release of coding modifications to the software version impacted.

Root Cause

Other

Distribution Pattern

Nationwide, UK, Ireland, Canada, Denmark, United Arab Emirates & Bermuda

Official Source

View FDA Recall →

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

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