Recall Z-1126-03 ยท LMB Device, Digital Image Storage, Radiological
Olympus America Inc.
Brand name: Olympus ImageManager Software, Versions 6.0 through 6.4 --- Common name: Medical image storage device. Class I, 510 (k) exempt.
| Date | Aug 12, 2003 (initiated Mar 5, 2003) |
| Status | Terminated |
| Reason | Software defect; potential under certain circumstances to incorrectly identify endoscopy images that have been uploaded & saved to the network system. |
| Root cause | Other |
| Action | 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. |
| Quantity | 856 |
| Distribution | Medical facilities nationwide and Puerto Rico; and 4 foreign accounts in Canada, Ecuador, Chile & Mexico. |
| FDA record | Open on fda.gov |