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
Versions 5.2, 5.23, & 5.3
Products Sold
Versions 5.2, 5.23, & 5.3
Misys Healthcare Systems is recalling Calculator/Data Processing Module for Clinical Use due to Software defect. Clinical Laboratory results failing quality assurance were filed directly to a patient's chart without review.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Software defect. Clinical Laboratory results failing quality assurance were filed directly to a patient's chart without review.
Recommended Action
Per FDA guidance
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.
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