Recall Z-1017-2017— Merge Healthcare, Inc.
Class II · Terminated
Class II FDA medical device recall by Merge Healthcare, Inc., initiated 2016-12-09, terminated 2021-03-24. It names one FDA 510(k) clearance: K913929. 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. Reason: This recall has been initiated due to an issue related to the potential accidental deletion of record(s) by an Eye Station user..
- Recalling firm
- Merge Healthcare, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-12-09
- Terminated
- 2021-03-24
- Firm location
- Hartland, WI, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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
Reason for recall
This recall has been initiated due to an issue related to the potential accidental deletion of record(s) by an Eye Station user.
Data sourced from openFDA. This site is unofficial and independent of the FDA.