Recall Z-2601-2017 ยท LLZ System, Image Processing, Radiological
Merge Healthcare, Inc.
Merge OrthoPACS software. The firm name on the label is Merge Healthcare, Hartland, WI.
| Date | May 24, 2017 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software design (manufacturing process) |
| Action | 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 respons |
| Quantity | 160 sites potentially have the affected versions |
| Distribution | USA (nationwide) Distribution was made to medical facilities. There was no foreign/government/military distribution. |
| FDA record | Open on fda.gov |