Recall Z-1700-2017 ยท LMB Device, Digital Image Storage, Radiological
Merge Healthcare, Inc.
iConnect Enterprise Archive software.
| Date | Apr 4, 2016 |
| Status | Terminated |
| Reason | The versions allow images to be stored without pixel data, resulting in the system not being able to present all the prior studies, which could cause a delay in treatment in determining the progression of disease. |
| 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 | 371 sites potentially have the affected software |
| Distribution | Distribution was nationwide to medical facilities. Foreign distribution was made to Canada, as well as other countries. Government and 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.