Merge Eye Station Import Utility (ESIU). The firm name on the labeling is Merge Healthcare.
This recall has been terminated (originally issued April 4, 2016).
- Company
- Merge Healthcare, Inc.
- Recall Initiated
- April 4, 2016
- Terminated
- June 15, 2020
- Recall Number
- Z-1498-2017
- Quantity
- 78 sites potentially have the affected accessory
- Firm Location
- Hartland, WI
- Official Source
- View on FDA website ↗
Reason for Recall
System locks up which may result in potential patient injury or delay in diagnosis or treatment.
Distribution
Distribution was made USA (nationwide) to medical facilities. Government distribution was made. Foreign distribution was made to Canada. There was no military distribution.
Lot / Code Info
Versions 1.1.2 and 1.1.3
Root Cause
Software design
Action Taken
Merge Healthcare, Inc. sent an Urgent: Medical Device Recall letter dated March 28, 2016, via email on April 4, 2016. If no email address was available, the letters were issued via certified mail. Nonresponders were issued letters dated July 11, 2016, via email. The letter notifies the customer of the issue and informs them of the workaround and that a fix was not yet available, although they were working on one. The notification instructs the customer to pass the information onto all other users, as well as any downstream customers if it was further distributed. The notification also informs the customer their response is required using the enclosed form and the return addressed envelope. The response form asks, in part, if they understand the workaround. The response was required no later than April 18, 2016. Nonresponders were issued a second letter dated July 11, 2016, asking for a response by August 2, 2016. The letter and response form contained the same information as the first letter. If the second letter results in additional unresponsive customers, a call campaign will be managed by Customer Support and documented via SalesForce. Three call attempts will made before closing the case. The recalling firm reported emails will be tracked for delivery confirmation and the letters will be tracked for delivery by USPS certified services. For further questions, please call (877) 741-5369.