Recall Z-1498-2017 ยท OUG Medical Device Data System
Merge Healthcare, Inc.
Merge Eye Station Import Utility (ESIU). The firm name on the labeling is Merge Healthcare.
| Date | Apr 4, 2016 |
| Status | Terminated |
| Reason | System locks up which may result in potential patient injury or delay in diagnosis or treatment. |
| Root cause | Software design |
| Action | Merge Healthcare, Inc. sent an Urgent: Medical Device Recall letter dated March 28, 2016, via email on April 4, 2016. If no email address was available, the letters were issued via certified mail. Nonresponders were issued letters dated July 11, 2016, via email. The letter notifies the customer of the issue and informs them of the workaround and that a fix was not yet available, although they were working on one. The notification instructs the customer to pass the information onto all other users, as well as any downstream customers if it was further distributed. The notification also info |
| Quantity | 78 sites potentially have the affected accessory |
| Distribution | Distribution was made USA (nationwide) to medical facilities. Government distribution was made. Foreign distribution was made to Canada. There was no military distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.