Olympus America Inc. Two Brand name: Olympus ImageManager Software, Versions 6.0 through 6.4 --- Common name: Medical image storage device. Class I, 510 (k) exempt. Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
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 --- Common name: Medical image storage device. Class I, 510 (k) exempt.
Brand
Olympus America Inc. Two
Lot Codes / Batch Numbers
Versions 6.0 through 6.4
Products Sold
Versions 6.0 through 6.4
Olympus America Inc. Two is recalling Brand name: Olympus ImageManager Software, Versions 6.0 through 6.4 --- Common name: Medical ima due to Software defect; potential under certain circumstances to incorrectly identify endoscopy images that have been uploaded & saved to the network system.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Software defect; potential under certain circumstances to incorrectly identify endoscopy images that have been uploaded & saved to the network system.
Recommended Action
Per FDA guidance
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.
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