FDA Enforcement
Class II
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
·
Reported September 28, 2016
Enforcement
- Recall Number
- Z-2865-2016
- Event ID
- 75034
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Merge Healthcare, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- September 28, 2016
- Initiation Date
- January 30, 2016
- Classification Date
- September 21, 2016
- Termination Date
- December 15, 2017
- Address
- 900 Walnut Ridge Dr, Hartland, WI, 53029-8347, United States
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.
Code Info
Version 10.1
Distribution
US Nationwide Distribution
Quantity
42 sites potentially have the affected version