Brand name: Olympus ImageManager Software, Versions 6.0 through 6.4 --- Common name: Medical image storage device. Class
FDA device recall Z-1126-03 · posted 2003-08-12 · Terminated
Recall details
- Recalling firm
- Olympus America Inc.
- Reason for recall
- Software defect; potential under certain circumstances to incorrectly identify endoscopy images that have been uploaded & saved to the network system.
- Action taken
- Olympus America, Inc. sent "Urgent-Device Correction" letters, dated 3/5/03, to the medical facilities, advising them of the software malfunction. The letter provides instructions to health care practitioners and that a new software release is being developed to prevent a recurrence.
- Root cause
- Other
- Status
- Terminated
- Product code
- LMB
- Quantity affected
- 856
- Distribution
- Medical facilities nationwide and Puerto Rico; and 4 foreign accounts in Canada, Ecuador, Chile & Mexico.
- Date initiated
- 2003-03-05
- Date posted
- 2003-08-12
- 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 |