Z-2620-2017 Class II Terminated
FDA device recall Z-2620-2017 was initiated by Merge Healthcare, Inc. on May 24, 2017 and is designated Class II. Reason for recall: A migrated study that has annotations will display the annotations, but when a prior study is loaded that should have annotations, the second study will not display annotations. The recall status is terminated (terminated June 28, 2019). Affected quantity: 98 sites potentially have the affected versions.
Recall Details
- Product Type
- Devices
- Report Date
- June 28, 2017
- Initiation Date
- May 24, 2017
- Termination Date
- June 28, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 98 sites potentially have the affected versions
Product Description
Merge OrthoPACS software.
Reason for Recall
A migrated study that has annotations will display the annotations, but when a prior study is loaded that should have annotations, the second study will not display annotations.
Distribution Pattern
Distribution was made nationwide to medical facilities. There was no foreign/government/military distribution.
Code Information
Versions 6.6, 6.6.1, and 6.6.2