Device product
Merge OfficePACS software. The firm name on the label is Merge Healthcare, Hartland, WI. OfficePACS is intended for the manipulation and displaying of medical images by a suitable licensed and qualified healthcare professional. It can show images from different modalities and interfaces to various image storage and printing devices using DICOM or similar interface standards. OrthoPACS also uses such images, in conjunction with templates for prosthetic devices, for the purposes of choosing the nature and characteristics of the prosthetic device to be used when planning a potential surgical procedure.
Z-2144-2016
Product summary
- Event
- Event 74522
- Status
- Terminated
- Classification
- Class II
- Quantity
- 216 sites have the affected software
- Official record key
device-enforcement:Z-2144-2016
Official wording
Reason: Potential data loss occurs as a result of the software archiving not working properly.
Code information: Software versions: 4.0, 4.1, 4.1.1, 4.1.2, and 4.2
Distribution pattern: The software was distributed nationwide to medical facilities. There was no government/military/foreign distribution.
Derived failure modes
-
Unknown
Potential data loss occurs as a result of the software archiving not working properly.