Z-0047-04

Brand name: Olympus ImageManager Software, Versions 6.0 through 6.4.1 (excluding version 6.3.8) Common name...

Name: Z-0047-04 Brand name: Olympus ImageManager Software, Versions 6.0 through 6.4.1 (excluding version 6.3.8) Common name...
Creator: Olympus America Inc.
Published: 2003-08-19
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2003-08-19 / Terminated / root cause: software

FDA source

Olympus America Inc. began a recall of 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)... on 2003-08-19. The reason FDA records is "Software malfunction; potential for simultaneous cross-linking of exam images to another patient's file". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0047-04
Status: Terminated
Initiated: 2003-08-19
Posted: 2003-10-15
Terminated: 2005-03-22
Recalling firm: OLYMPUS Corporation of the Americas
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.)
Product code: LMB Device, Digital Image Storage, Radiological
Reason for recall: Software malfunction; potential for simultaneous cross-linking of exam images to another patient's file.
Root cause tag: software
FDA 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 in commerce: 1014
Distribution: Medical facilities (end users) nationwide and Puerto Rico, plus 5 foreign accounts located in Canada, Mexico, Ecuador and Chile.
Product codes and lots: Versions 6.0 through 6.4.1 (excluding version 6.3.8)

Product code LMB

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)