Z-2601-2017 Class II Terminated
FDA device recall Z-2601-2017 was initiated by Merge Healthcare, Inc. on May 24, 2017 and is designated Class II. 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. The recall status is terminated (terminated October 15, 2019). Affected quantity: 160 sites potentially have the affected versions.
Recall Details
- Product Type
- Devices
- Report Date
- June 28, 2017
- Initiation Date
- May 24, 2017
- Termination Date
- October 15, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 160 sites potentially have the affected versions
Product Description
Merge OrthoPACS software. The firm name on the label is Merge Healthcare, Hartland, WI.
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 Pattern
USA (nationwide) Distribution was made to medical facilities. There was no foreign/government/military distribution.
Code Information
Versions 6.6, 6.6.1, 6.6.2, 6.6.2.1, and 6.6.2.2