FDA Recall
Terminated
Merge Cardio software. Product Usage: Merge Cardio is an integrated cardiovascular information system classified as a picture archiving and communications system.
Recall: Z-2865-2016
·
Initiated January 30, 2016
Recall
- Recall Number
- Z-2865-2016
- Event Number
- 75034
- Firm
- Merge Healthcare, Inc.
- FEI Number
- 1000116130
- Product Code
- LLZ
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- January 30, 2016
- Terminated
- December 15, 2017
- Address
- 900 Walnut Ridge Dr, Hartland, WI, 53029-8347
Description
Merge Cardio software. Product Usage: Merge Cardio is an integrated cardiovascular information system classified as a picture archiving and communications system.
Reason
Patient information in the header is only found on the first page of the report and not on the subsequent pages.
Action
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 [email protected].
Distribution
US Nationwide Distribution
Quantity
42 sites potentially have the affected version