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.
This recall has been terminated (originally issued July 8, 2016).
- Company
- Merge Healthcare, Inc.
- Recall Initiated
- January 30, 2016
- Posted
- July 8, 2016
- Terminated
- February 3, 2017
- Recall Number
- Z-2144-2016
- Quantity
- 216 sites have the affected software
- Firm Location
- Hartland, WI
- Official Source
- View on FDA website ↗
Reason for Recall
Potential data loss occurs as a result of the software archiving not working properly.
Distribution
The software was distributed nationwide to medical facilities. There was no government/military/foreign distribution.
Lot / Code Info
Software versions: 4.0, 4.1, 4.1.1, 4.1.2, and 4.2
Root Cause
Software design
Action Taken
Merge Healthcare sent an Urgent Medical Device Recall letter dated January 26, 2016, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customers. Customers were instructed to provide a copy of the notification to all users. For additional questions customers were advised to call Merge Customer Service at (87) 741-5369. For questions regarding this recall call 262-367-0700.