Recall Z-1017-2017 ยท HKI Camera, Ophthalmic, Ac-Powered
Merge Healthcare, Inc.
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
| Date | Dec 9, 2016 |
| Status | Terminated |
| Reason | This recall has been initiated due to an issue related to the potential accidental deletion of record(s) by an Eye Station user. |
| Root cause | Software design |
| Action | Consignees were sent on 12/9/2016 a Merge "Urgent Medical Device Recall" letter. The letter was addressed to Office Manager and Recall # 216-078. The letter described the Product, Issue, Potential Harm, Containment by the Customer / User, Action by Merge and Actions by Customer. Requested consignees to provide response to the "Response to this Notification is Required". If the product was further distributed advised consignees to notify them at once. For questions send an e-mail to recall@merge.com. E-mails to be sent to consignees on 12/19/2016. |
| Quantity | 1597 (1451 US; 146 OUS) |
| Distribution | 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, Ne |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K913929 | DFC-1024 & DFC-512 DIGITAL IMAGING SYSTEM Ophthalmic Imaging Systems, Nov 27, 1991 |