FDA Device Recall Z-0007-04: Misys Healthcare Systems

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0007-04.

Recall Res Number

Z-0007-04

Recalling Firm / Manufacturer

Misys Healthcare Systems

FEI Number

1000306472

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2003-08-12

Date Posted

2004-07-20

Date Terminated

2004-03-15

Product Code

JQP

Event Number

27077

Product Quantity

479

Product Description Calculator/Data Processing Module for Clinical Use

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

Action Details 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.

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

Code Information / Serial Numbers Versions 5.2, 5.23, & 5.3

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Medical Device Recall: Z-0007-04

Recall Parameters & Description

Related Establishments / Registrations

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