Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Image processing system.
This recall has been terminated (originally issued September 1, 2016).
- Company
- Merge Healthcare, Inc.
- Recall Initiated
- February 9, 2016
- Posted
- September 1, 2016
- Terminated
- August 24, 2017
- Recall Number
- Z-2709-2016
- Quantity
- 116 customers potentially have the affected versions
- Firm Location
- Hartland, WI
- Official Source
- View on FDA website ↗
Reason for Recall
A report can be confirmed with the incorrect patient demographics resulting in it being saved under the incorrect patient record in the Electronic Medical Record (EMR).
Distribution
Nationwide Distribution
Lot / Code Info
Versions 10.1 and 10.1.1
Root Cause
Software design
Action Taken
MERGE sent an Urgent Medical Device Recall letter dated February 9, 2016, to all affected customers via email or via certified mail if they did not have an e-mail address for the customer. The notification instructs the customer to pass the information onto all other users, as well as any downstream customers if it was further distributed. In addition, the customer is requested to call Customer Service or send them an email to schedule the upgrade. If the customer chooses not to upgrade, they are requested to complete the attached form or go online and complete it. For further questions, please call (800) 724-5970 ext. 8027.