Olympus America Inc. Two 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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.)
Brand
Olympus America Inc. Two
Lot Codes / Batch Numbers
Versions 6.0 through 6.4.1 (excluding version 6.3.8)
Products Sold
Versions 6.0 through 6.4.1 (excluding version 6.3.8)
Olympus America Inc. Two is recalling Brand name: Olympus ImageManager Software, Versions 6.0 through 6.4.1 (excluding version 6.3.8) Co due to Software malfunction; potential for simultaneous cross-linking of exam images to another patient's file.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Software malfunction; potential for simultaneous cross-linking of exam images to another patient's file.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026