Class 2 Device Recall

• Date Initiated by Firm: July 07, 2003
• Date Posted: July 20, 2004
• Recall Status: Terminated on September 23, 2004
• Recall Number: Z-0151-04
• Recall Event ID: 26789
• Product Classification: Calculator/Data Processing Module, For Clinical Use - Product Code JQP
• Product: Misys Laboratory System, Versions 5.2, 5.23, 5.3 up to 5.3.2.
• Code Information: Versions 5.2, 5.23, 5.3 up to 5.3.2.
• FEI Number: 1000306472
• Recalling Firm/ Manufacturer: Misys Healthcare Systems; 4801 E Broadway Blvd; Tucson AZ 85711
• For Additional Information Contact: Barbara Brown; 520-733-6403
• Manufacturer Reason for Recall: Software defect causes orders to be lost under certain conditions of use. A typographical error at the Accept/Modfy/Reject prompt will cause the order not to be processed by the system.
• FDA Determined Cause: Other
• Action: Product Safety Notice PSN-03-L32 was issued by fax to customers on July 7, 2003. It communcated a procedural workaround and that a follow-up notification was pending completion of a software engineering project to correct the defect.
• Quantity in Commerce: 473
• Distribution: Nationwide and to United Kingdom, Ireland, Denmark, Canada, Bermuda, Saudi Arabia, United Arab Emirates,
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.