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Recall Observatory FDA recall evidence

Device product

iConnect Enterprise Archive (ICEA) software. The firm name on the labeling is Merge Healthcare, Hartland, WI.

Z-1762-2017

April 04, 2016

Class II

Product summary

Firm
Merge Healthcare, Inc.
Event
Event 76910
Status
Terminated
Classification
Class II
Quantity
333 sites potentially have the affected versions
Official record key
device-enforcement:Z-1762-2017

Official wording

Reason: An error message can occur resulting in the prior studies being unavailable for viewing.

Code information: 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

Distribution pattern: Distribution was made nationwide to medical facilities. Foreign distribution was made to Canada, as well as other countries. Government/military distribution was also made.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    An error message can occur resulting in the prior studies being unavailable for viewing.