FDA Medical Device Recalls (openFDA)
Misys Healthcare Systems: Calculator/Data Processing Module for Clinical Use
- Recall number
- Z-0007-04
- Recalling firm
- Misys Healthcare Systems
- Product
- Calculator/Data Processing Module for Clinical Use
- Status
- Terminated
- Initiated
- 2003-08-12
- Posted
- 2004-07-20
- Terminated
- 2004-03-15
- Reason
- Software defect. Clinical Laboratory results failing quality assurance were filed directly to a patient's chart without review.
- Root cause
- Other
- 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.
- Quantity
- 479
- Distribution
- Nationwide, UK, Ireland, Canada, Denmark, United Arab Emirates & Bermuda
- Lot, serial or model codes
- Versions 5.2, 5.23, & 5.3
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JQP
- Firm FEI
- 1000306472
- Firm city
- Tucson
- Firm state
- AZ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28