Misys Healthcare Systems Calculator/ Data Processing Module for Clinical Use Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Calculator/ Data Processing Module for Clinical Use
Brand
Misys Healthcare Systems
Lot Codes / Batch Numbers
Verison 5.3 through 5.3.2
Products Sold
Verison 5.3 through 5.3.2
Misys Healthcare Systems is recalling Calculator/ Data Processing Module for Clinical Use due to Software Defect. Data used in the diagnosis and or treatment of a patient's illness are missing from the patient result report.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Software Defect. Data used in the diagnosis and or treatment of a patient's illness are missing from the patient result report.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026