International Medical Devices Database

Manufacturer Address
Olympus America Inc., Two Corporate Center Drive, Melville NY 11747
Source
USFDA
2 Events
- Recall of Device Recall Olympus ImageManager Software
- Recall of Device Recall Olympus ImageManager

2 devices in the database

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.)

Device Recall Olympus ImageManager

Model / Serial
Versions 6.0 through 6.4
Product Classification
Radiology Devices
Device Class
1
Implanted device?
No
Distribution
Medical facilities nationwide and Puerto Rico; and 4 foreign accounts in Canada, Ecuador, Chile & Mexico.
Product Description
Brand name: Olympus ImageManager Software, Versions 6.0 through 6.4 --- Common name: Medical image storage device. Class I, 510 (k) exempt.

4 manufacturers with a similar name

Learn more about the data here

Olympus America Inc.

Manufacturer Address
Olympus America Inc., 3500 Corporate Pkwy., P.O. Box 610, Center Valley PA 18034-0610
Manufacturer Parent Company (2017)
Olympus Corporation
Source
USFDA

Olympus America Inc.

Manufacturer Parent Company (2017)
Olympus Corporation
Source
BAM

OLYMPUS AMERICA INC. DIAGNOSTIC SYSTEMS GROUP

Manufacturer Address
CENTER VALLEY
Manufacturer Parent Company (2017)
Olympus Corporation
Source
HC

OLYMPUS AMERICA INC. (DIAGNOSTIC SYSTEMS GROUP)

Manufacturer Address
MELVILLE
Source
HC

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Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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