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Recall Observatory FDA recall evidence

Device product

Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.

Z-2301-2016

January 30, 2016

Class II

Product summary

Firm
Merge Healthcare, Inc.
Event
Event 74648
Status
Terminated
Classification
Class II
Quantity
109 sites have the affected versions
Official record key
device-enforcement:Z-2301-2016

Official wording

Reason: Studies coming over via telmed were missing patient's DOB, procedure, and referring physician.

Code information: Versions: V6.0 MR4 CU 1-11, 6.1.0, 6.1.1, 6.1.1.1, 6.1.2, 6.1.3, 6.1.3.1, 6.2.0, 6.2.1, 6.2.2, 6.2.2.1, and 6.2.3.

Distribution pattern: Worldwide Distribution -- USA, New Zealand, and United Kingdom.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Studies coming over via telmed were missing patient's DOB, procedure, and referring physician.