Recall Z-1697-2017
Merge Healthcare, Inc. · initiated April 4, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
iConnect Enterprise Archive (ICEA) software. iConnect Enterprise Archive is intended for use as a vendor neutral archive for storage and communications of medical images and data
Codes / lots: Versions 8.30, 8.30.2, 8.40.0, 8.40.1, 8.40.2, 8.40.2.1, 8.40.2.2, 8.70, 8.80, 8.80.0.1, 8.80.0.2, 8.80.1.1, 8.80.2, 9.0.0, 9.0.0.1, 9.1.0, 9.1.1, 9.1.2, 9.1.2.1, 9.2.0, 9.3.0, 9.3.1, 9.4, 9.4.1, 9.4.2, 9.4.2.1, and 9.4.3.
Reason for recall
The study is archived but cannot be opened in iConnect Access and cannot send to PACS resulting in comparison studies not being available for physician review to determine the progression of disease.
FDA-determined cause: Software design
Action taken
MERGE sent an Urgent Medical Device Recall letter dated July 11, 2016, to all affected customers. 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.
Details
- Recall number
- Z-1697-2017
- Initiated
- April 4, 2016
- Terminated
- April 10, 2020
- Product code
- LMB – Device, Digital Image Storage, Radiological
- Quantity
- 298 sites potentially have the affected versions (290 of those in US)
- Distribution
- Worldwide Distribution - US (nationwide) and Internationally to Canada, Belgium, Australia, Jordan, and the UK..
- Recalling firm
- Merge Healthcare, Inc., Hartland, WI