EVMS (Enterprise Visual Medical System); Picture archiving and communications system; Model Numbers: 5.30.4, 5.30.5, 5.3
FDA device recall Z-1644-2008 · posted 2008-05-28 · Terminated
Recall details
- Recalling firm
- Emageon
- Reason for recall
- Miscalculation: The calculation of the standard uptake value does not include the required calibration factor/decay correction factor. The resulting value is incorrectly calculated, which may lead to incorrect interpretation of tissue density. The calculation error exists in both the software and user guide.
- Action taken
- Consignees were notified by Urgent Device Correction letters that were sent on 1/9/08 and 1/18/08. The letters instructed users not to use the standard uptake value in EVMS for diagnostic interpretation when viewing PET studies unless they received service bulletin 445, 446 or 7.0.1. Users were also instructed to replace pages in the user's guide with the pages provided and to affix the enclosed warning sticker on all workstations. Users will be contacted by the recalling firm to schedule a software patch.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 99
- Distribution
- Nationwide Distribution including states of: MI, WI, CA, MN, AZ, CO, MN, MD, DC, MO, TX, IL, GA, FL, WI, SC, PA, NY, KS, TN, AL and OK.
- Date initiated
- 2008-01-01
- Date posted
- 2008-05-28
- Date terminated
- 2009-06-11
- Location
- Hartland, WI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EVMS (ENTERPRISE VISUAL MEDICAL SYSTEM SOFTWARE) (K053281) | Emageon, Inc. | 2005-12-07 |