FDA Device recall Z-2144-2016
Merge OfficePACS software
- FDA Device
- Class II
- terminated
- Published 2016-07-20
On 2016-07-20 the FDA classified a Class II recall of Merge OfficePACS software by Merge Healthcare, citing potential data loss occurs as a result of the software archiving not working properly.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2144-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-01-30 |
| Published | 2016-07-20 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Merge Healthcare |
| Distribution | US |
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.
Reason
Potential data loss occurs as a result of the software archiving not working properly.
Identifiers
| code_info | Software versions: 4.0, 4.1, 4.1.1, 4.1.2, and 4.2 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2144-2016%22
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