Device product
Merge Eye Station f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStation, and WinStation Retinal Imager distributed by Ophthalmic Imaging Systems (OIS). Versions: 11.6.0 and prior
Z-1017-2017
Product summary
- Event
- Event 75602
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1597 (1451 US; 146 OUS)
- Official record key
device-enforcement:Z-1017-2017
Official wording
Reason: This recall has been initiated due to an issue related to the potential accidental deletion of record(s) by an Eye Station user.
Code information: Merge Eye Station software versions: 11.6.0 and prior
Distribution pattern: US: Alabama, Alaska, Arizona,Arkansas, California,Colorado,Connecticut,Delaware, District of Columbia, Georgia,Hawaii, Idaho, Illinois,Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland,Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Florida, Tennessee, Wyoming. OUS: Czech Republic Algeria Belgium Brazil Canada Denmark France Germany Greece India Israel Italy Korea, Republic of Luxembourg Netherlands Poland Russian Federation Singapore United Kingdom
Derived failure modes
-
Unknown
This recall has been initiated due to an issue related to the potential accidental deletion of record(s) by an Eye Station user.