Devices

Device Recall Olympus ImageManager Software

Model / Serial
Versions 6.0 through 6.4.1 (excluding version 6.3.8)
Product Classification
Radiology Devices
Device Class
1
Implanted device?
No
Distribution
Medical facilities (end users) nationwide and Puerto Rico, plus 5 foreign accounts located in Canada, Mexico, Ecuador and Chile.
Product Description
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.)
Manufacturer
Olympus America Inc.
1 Event
- Recall of Device Recall Olympus ImageManager Software

Manufacturer

Olympus America Inc.

Manufacturer Address
Olympus America Inc., Two Corporate Center Drive, Melville NY 11747
Source
USFDA

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