FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-1126-03
- Recalling firm
- Olympus America Inc.
- Product
- Brand name: Olympus ImageManager Software, Versions 6.0 through 6.4 --- Common name: Medical image storage device. Class I, 510 (k) exempt.
- Status
- Terminated
- Initiated
- 2003-03-05
- Posted
- 2003-08-12
- Terminated
- 2005-03-22
- 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.
- Lot, serial or model codes
- Versions 6.0 through 6.4
- 510(k) numbers
- K934888, K934889
- PMA numbers
- not on file
- Product code
- LMB
- Firm FEI
- 2429304
- Firm city
- Melville
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28