Merge OrthoPACS software. The firm name on the label is Merge Healthcare, Hartland, WI.
This recall has been terminated (originally issued May 24, 2017).
- Company
- Merge Healthcare, Inc.
- Recall Initiated
- May 24, 2017
- Terminated
- October 15, 2019
- Recall Number
- Z-2601-2017
- Quantity
- 160 sites potentially have the affected versions
- Firm Location
- Hartland, WI
- Official Source
- View on FDA website ↗
Reason for Recall
Studies that have QC, PDE, or HL7 ADT updates applied may fail to propagate via telmed protocol to the destination server and may fail to import on the destination server.
Distribution
USA (nationwide) Distribution was made to medical facilities. There was no foreign/government/military distribution.
Lot / Code Info
Versions 6.6, 6.6.1, 6.6.2, 6.6.2.1, and 6.6.2.2
Root Cause
Software design (manufacturing process)
Action Taken
Merge Healtcare sent an Urgent Medical Device Recall letter dated May 19, 2017, via email on May 24, 2017. The letter notifies the customer of the issue, informs them to be aware of the workaround, and that a fix is available for the issue in Merge OrthoPACS 6.6.3.2 (or later). 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 15 calendar days after receipt of the recall letter using the enclosed form. The response form asks, in part, if they are interested in accepting the fix. If they decline the fix, they are asked to provide the reason why. The recalling firm will contact all unresponsive customers with a second customer letter, followed by a third customer letter. They may additionally contact customers that are unresponsive via telephone. For further questions, please call ( 877) 741-5369.