FDA Medical Device Recalls (openFDA)
Olympus America Inc.: Brand name: Olympus ImageManager Software, Versions 6.0 through 6.4.1 (excluding version 6.3.8) Common name: Medical image storage device. Class I, 510 (k) exempt. (NOTE: any ImageManager Software sold as a stand-alone system is not impacted by this software malfunction since no opportunity exists for any image cross-linking. It is a condition of the software malfunction that the observed image crosslink results from the collision of data files from two separate ImageManager computers.)
- Recall number
- Z-0047-04
- Recalling firm
- Olympus America Inc.
- Product
- Brand name: Olympus ImageManager Software, Versions 6.0 through 6.4.1 (excluding version 6.3.8) Common name: Medical image storage device. Class I, 510 (k) exempt. (NOTE: any ImageManager Software sold as a stand-alone system is not impacted by this software malfunction since no opportunity exists for any image cross-linking. It is a condition of the software malfunction that the observed image crosslink results from the collision of data files from two separate ImageManager computers.)
- Status
- Terminated
- Initiated
- 2003-08-19
- Posted
- 2003-10-15
- Terminated
- 2005-03-22
- Reason
- Software malfunction; potential for simultaneous cross-linking of exam images to another patient's file.
- Root cause
- Other
- Action
- 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.
- Quantity
- 1014
- Distribution
- Medical facilities (end users) nationwide and Puerto Rico, plus 5 foreign accounts located in Canada, Mexico, Ecuador and Chile.
- Lot, serial or model codes
- Versions 6.0 through 6.4.1 (excluding version 6.3.8)
- 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