FDA Device

Merge Cardio software. Product Usage: Merge Cardio is an integrated cardiovascular information system classified as a picture archiving and communications system.

Hazard

Patient information in the header is only found on the first page of the report and not on the subsequent pages.

What You Should Do

Remedy

Merge sent an Urgent Medical Device Recall letter dated January 28, 2016 to affected customers via e-mail or via certified mail if they did not have an e-mail address. The letter identified the affected product, problem and actions to be taken. For questions call Merge Customer Service at (877)741-5369 or support@merge.com.

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Products

Merge Cardio software. Product Usage: Merge Cardio is an integrated cardiovascular information system classified as a picture archiving and communications system.
Brand
Merge Healthcare, Inc.
UPC
Version 10.1

Units Affected

42 sites potentially have the affected version

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