FDA Medical Device Recalls (openFDA)
Misys Healthcare Systems: Mysis Laboratory version 6.1
- Recall number
- Z-0939-05
- Recalling firm
- Misys Healthcare Systems
- Product
- Mysis Laboratory version 6.1
- Status
- Terminated
- Initiated
- 2005-05-10
- Posted
- 2005-06-28
- Terminated
- 2005-08-30
- Reason
- When a previously reported microbiology organism result is deleted on a selected patient, reported susceptibilities will not stay with associated organisms and one or more suceptibilities on the culture will be deleted.
- Root cause
- Other
- Action
- Firm sent Product Safety Notice PSN 05-02 on May 10, 2005 which also provides a procedural work-around and an invitation to obtain a service pack to correct the software flaw.
- Quantity
- 21
- Distribution
- Nationwide and United Kingdom and Denmark
- Lot, serial or model codes
- Version 6.1
- 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