Recall Z-0047-04 ยท LMB Device, Digital Image Storage, Radiological
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 imag
| Date | Oct 15, 2003 (initiated Aug 19, 2003) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |