Company: Merge Healthcare, Inc.
Date of Enforcement Report 8/10/2016
Class lI:
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.
Recall Number Z-2301-2016
REASON
Studies coming over via telmed were missing patient’s DOB, procedure, and referring physician.
RECALLING FIRM/MANUFACTURER
Merge Healthcare, Inc. Hartland, WI on 1/30/2016 Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
109 sites
DISTRIBUTION
USA, New Zealand, and United Kingdom.
___________________________________
