FDA-Device2016-08-10Class II
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.
Merge Healthcare, Inc.
Hazard
Studies coming over via telmed were missing patient's DOB, procedure, and referring physician.
Sold states
Worldwide Distribution -- USA, New Zealand, and United Kingdom.
Affected count
109 sites have the affected versions
Manufactured in
900 Walnut Ridge Dr, Hartland, WI, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2301-2016Don't want to check this manually?
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