Calculator/Data Processing Module for Clinical Use
FDA device recall Z-0007-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Misys Healthcare Systems
- Reason for recall
- Software defect. Clinical Laboratory results failing quality assurance were filed directly to a patient's chart without review.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- JQP
- Quantity affected
- 479
- Distribution
- Nationwide, UK, Ireland, Canada, Denmark, United Arab Emirates & Bermuda
- Date initiated
- 2003-08-12
- Date posted
- 2004-07-20
- Date terminated
- 2004-03-15
- Location
- Tucson, AZ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.