iConnect Enterprise Archive (ICEA) software. The firm name on the labeling is Merge Healthcare, Hartland, WI.
This recall has been terminated (originally issued April 5, 2017).
- Company
- Merge Healthcare, Inc.
- Recall Initiated
- April 4, 2016
- Posted
- April 5, 2017
- Terminated
- June 15, 2020
- Recall Number
- Z-1762-2017
- Quantity
- 333 sites potentially have the affected versions
- Firm Location
- Hartland, WI
- Official Source
- View on FDA website ↗
Reason for Recall
An error message can occur resulting in the prior studies being unavailable for viewing.
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.
Lot / Code Info
Versions : 8.30, 8.30.2, 8.40.0, 8.40.1, 8.40.1 HF0557, 8.40.s, 8.40.2.1, 8.40.2.2, 8.80, 8.80.0.1, 8.80.1.1, 8.80.2, 8.80.0.2, 9.0.0, 9.0.0.1, 9.1.0, 9.1.1, 9.1.2, 9.1.2.1, 9.1.2.2, 9.2.0, 9.3.0, 9.3.1, 9.4.0, 9.4.1, 9.4.2, 9.4.2.1., and 9.4.3
Root Cause
Software design
Action Taken
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.