IntelePACS Picture Archiving Communications System InteleViewer Workstation Model #3.X.X.
FDA device recall Z-1884-2009 · posted 2009-08-27 · Terminated
Recall details
- Recalling firm
- Intelerad Medical Systems Inc.
- Reason for recall
- Product software versions 3.5.2.P1 to 3.5.2.p56 inclusive and 3.6.1.P1 to 3.6.1.P82 inclusive were defective.
- Action taken
- Intelerad Medical Systems issued an Urgent Medical Device Filed Safety Notice" dated October 24, 2008 describing the affected product and steps required for system upgrade. Users are requested to complete and return an acknowledgement form via email to quality@intelerad.com. For further information, contact Intelerad Medical Systems at 1-514-931-6222.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 1
- Distribution
- Worldwide Distribution -- United States (NM, AZ, CT, MN, TX, NC, TN, FL and CO), Canada, Australia, and New Zealand.
- Date initiated
- 2008-10-27
- Date posted
- 2009-08-27
- Date terminated
- 2010-09-24
- Location
- Montreal, Canada
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INTELEPACS (K070080) | Intelerad Medical Systems, Inc. | 2007-01-24 |