Recall Z-1762-2017 ยท LMB Device, Digital Image Storage, Radiological
Merge Healthcare, Inc.
iConnect Enterprise Archive (ICEA) software. The firm name on the labeling is Merge Healthcare, Hartland, WI.
| Date | Apr 5, 2017 (initiated Apr 4, 2016) |
| Status | Terminated |
| Reason | An error message can occur resulting in the prior studies being unavailable for viewing. |
| Root cause | Software design |
| Action | The recalling firm issued a letter dated 3/28/2016 via e-mail the week of 4/4/2016. If no email address was available, the letters were issued via certified mail. A second letter dated 7/11/2016 was issued to nonresponders. |
| Quantity | 333 sites potentially have the affected versions |
| Distribution | Distribution was made nationwide to medical facilities. Foreign distribution was made to Canada, as well as other countries. Government/military distribution was also made. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.