ILUMAVision Software, version 2.1.0 Picture Archiving and Communication system Product used as a tool for the pre-surgic
FDA device recall Z-2239-2009 · posted 2009-09-22 · Terminated
Recall details
- Recalling firm
- IMTEC IMAGING L.L.C.
- Reason for recall
- Under certain circumstances, software Version 2.1.0 has potential for incorrect data imaging and patient identification.
- Action taken
- Firm sent notifications to all ILUMAVision customers on 8/3/2009 and offered upgraded software. The notification letter indicated the the reason for the recall and identified the potential issues associated with the device. Contact 3M IMTEC Technical Support at 1.800.879.9799, if there are any questions.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 223
- Distribution
- Worldwide - US - Foreign: Australia, Austria, Belgium, Bulgaria, Canada, Croatia, Egypt, France, Germany, Hong Kong, Italy, Korea, Malaysia, Mexico, The Netherlands, Poland, Saudi Arabia, Spain, Turke
- Date initiated
- 2009-08-03
- Date posted
- 2009-09-22
- Date terminated
- 2010-01-27
- Location
- Ardmore, OK
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ILUMA VISION (K081347) | Imtec Corp. | 2008-05-28 |