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.
Enforcement
- Recall Number
- Z-2144-2016
- Event ID
- 74522
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Merge Healthcare, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- July 20, 2016
- Initiation Date
- January 30, 2016
- Classification Date
- July 8, 2016
- Termination Date
- February 3, 2017
- Address
- 900 Walnut Ridge Dr, Hartland, WI, 53029-8347, United States
Description
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.
Potential data loss occurs as a result of the software archiving not working properly.
Software versions: 4.0, 4.1, 4.1.1, 4.1.2, and 4.2
The software was distributed nationwide to medical facilities. There was no government/military/foreign distribution.
216 sites have the affected software