iConnect Enterprise Archive (ICEA) software. The firm name on the labeling is Merge Healthcare, Hartland, WI.
FDA device recall Z-1762-2017 · posted 2017-04-05 · Terminated
Recall details
- Recalling firm
- Merge Healthcare, Inc.
- Reason for recall
- An error message can occur resulting in the prior studies being unavailable for viewing.
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LMB
- Quantity affected
- 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.
- Date initiated
- 2016-04-04
- Date posted
- 2017-04-05
- Date terminated
- 2020-06-15
- Location
- Hartland, WI
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