Recall Z-2144-2016 ยท LLZ System, Image Processing, Radiological
Merge Healthcare, Inc.
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 s
| Date | Jul 8, 2016 (initiated Jan 30, 2016) |
| Status | Terminated |
| Reason | Potential data loss occurs as a result of the software archiving not working properly. |
| Root cause | Software design |
| Action | 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. |
| Quantity | 216 sites have the affected software |
| Distribution | The software was distributed nationwide to medical facilities. There was no government/military/foreign distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033825 | ORTHOPACS Etrauma.Com Corp., Feb 2, 2004 |