Recall Z-1470-2017 ยท LMB Device, Digital Image Storage, Radiological
Merge Healthcare, Inc.
iConnect Enterprise Archive when used with RadSuite. The firm name on the label is Merge Healthcare.
| Date | Mar 10, 2017 (initiated Apr 4, 2016) |
| Status | Terminated |
| Reason | The software produced a number of "do not route" exceptions, which may result in potential patient injury or delay in diagnosis or treatment. |
| Root cause | Software design |
| Action | Merge Healthcare sent an Urgent: Medical Device Recall letter dated March 28, 2016, via e-mail the week of April 4, 2016. If no email address was available, the letters were issued via certified mail. A second letter dated July 11, 2016, was issued to nonresponders. The letter notifies the customer of the issue and informs them a fix has been released for the issue. 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 informs the customer their response is required u |
| Quantity | 187 sites potentially have the affected versions |
| Distribution | USA (nationwide ) Distribution to medical facilities. Government distribution was also made. There was no foreign or military distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K053281 | EVMS (ENTERPRISE VISUAL MEDICAL SYSTEM SOFTWARE) Emageon, Inc., Dec 7, 2005 |