Brand name: Olympus ImageManager Software, Versions 6.0 through 6.4.1 (excluding version 6.3.8) Common name: Medical ima
FDA device recall Z-0047-04 · posted 2003-10-15 · Terminated
Recall details
- Recalling firm
- Olympus America Inc.
- Reason for recall
- Software malfunction; potential for simultaneous cross-linking of exam images to another patient's file.
- Action taken
- OAI sent "Urgent-Device Correction" letters, dated 8/19/03, to the end users, explaining the software malfunction. The letter also provided specific instructions to the end users until the software fix is installed. For technical assistance, users can contact OAI's Technical Assistance Center 1-800-848-9024. Accompanying the letter is a questionnaire to be completed by the end users & returned to OAI for scheduling an appointment to visit the facility to install the software fix.
- Root cause
- Other
- Status
- Terminated
- Product code
- LMB
- Quantity affected
- 1014
- Distribution
- Medical facilities (end users) nationwide and Puerto Rico, plus 5 foreign accounts located in Canada, Mexico, Ecuador and Chile.
- Date initiated
- 2003-08-19
- Date posted
- 2003-10-15
- Date terminated
- 2005-03-22
- Location
- Melville, NY
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OLYMPUS IMAGEMANAGER SYSTEM (K934889) | Olympus | 1994-01-28 |
| OLYMPUS IMAGEMANAGERSYSTEM (K934888) | Olympus | 1994-01-25 |