Recall Z-1142-2017 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). Model number 136 T1700 Capture Stations & 46 T5810 Capture Stations.
| Date | Dec 9, 2016 |
| Status | Terminated |
| Reason | Merge received reports of Merge Eye Station being unable to capture images of the eye as expected per the intended use of the product. Merge is recalling product from the field to reduce the risk to patient health. |
| Root cause | Software design |
| Action | Merge sent an Urgent Medical Device Recall letter on December 9, 2016. The letter was addressed to Office Manager . The letter described the Product, Issue, Potential Harm, Containment by the Customer / User, Action by Merge and Actions by Customer. Requested customers 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. For further questions, please call (262) 367- 0700. |
| Quantity | 182 capture stations |
| Distribution | Worldwide Distribution - USA (nationwide) including the states of : CA, CO, CT, FL, HI, IL, IN, LA, MD, MA,M I, MN, MS. MK. NY, NC,ND, OH, OK, OR, PA, RI, TN, VA, WA and WV., and the countries of Canada and United Kingdom. |
| 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 |