Merge OfficePACS Software Recalled for Potential Data Loss
Merge Healthcare is recalling OfficePACS software version 3.4 because archiving failures may cause data loss at 49 medical facilities.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is potential data loss, which is a significant operational risk but does not involve direct physical injury or death, fitting the Moderate category for non-physical hazards without reported harm.
Plain-English summary
Merge Healthcare, Inc. is recalling Merge OfficePACS software, version 3.4. The recall is due to a defect where the product archiving function does not work properly, which can result in potential data loss.
The affected software was distributed to 49 medical facilities located in Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Kentucky, Massachusetts, Missouri, Nebraska, New Hampshire, New Jersey, New York, North Carolina, Oklahoma, Pennsylvania, South Carolina, Tennessee, Virginia, and Washington. There was no distribution to government, military, or foreign entities.
Healthcare facilities using this software should contact Merge Healthcare for instructions on how to resolve the archiving issue and prevent data loss.
The recalled product
- Product
- Merge OfficePACS software. The firm name on the label is Merge Healthcare, Heartland, WI.
- Manufacturer
- Merge Healthcare, Inc.
- Category
- Medical Device — Software
- Hazard
- Affected units
- 49
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Version 3.4
Distribution
Related recalls
Same manufacturer · Merge Healthcare, Inc.
See all →- HighMerge Healthcare Recalls PACS Workstations Due to Inaccurate Measurements
FDA (Devices) · 2026-09-02
- HighMerge PACS Medical Imaging Workstation Recalled Due to Patient Data Display Error
FDA (Devices) · 2026-08-12
- SevereMerge OrthoPACS Imaging Workstation Recall for Patient Data Display Issue
FDA (Devices) · 2026-08-12
- ModerateHemodynamic recording systems recalled over pressure sensor error during blood pressure measurement
FDA (Devices) · 2025-09-10
- HighVERICIS Merge Cardio Medical Device Software Measurement Data Consistency Issue
FDA (Devices) · 2025-03-26
Same hazard · data loss
See all →- HighPhilips Fluoroscopy System Recall Over Hard Disk Drive Issue
FDA (Devices) · 2026-08-12
- SeverePhilips Allura X-Ray Systems Recalled Over Unauthorized Hard Disk Drives
FDA (Devices) · 2026-08-12
- HighRayCare 2024A SP1 Oncology Information System Software Recall
FDA (Devices) · 2026-07-08
- HighRayCare 2024A SP4 Oncology System Beam Set Delivery Note Data Loss
FDA (Devices) · 2026-07-08
- HighMint Lesion Software Data Loss During Server Connection Interruption
FDA (Devices) · 2026-05-13
Similar recalls
- ModerateMerge Healthcare Recalls OfficePACS Software Due to Data Loss Risk
FDA (Devices) · 2016-07-20
- ModerateMerge OrthoPACS software recalled due to data propagation failures
FDA (Devices) · 2017-06-28
- HighMerge PACS Software Recalled for Potential Incorrect Patient Image Display
FDA (Devices) · 2017-02-15
- HighMerge PACS Software Recalled for Potential Image Display Defect
FDA (Devices) · 2017-06-21
- HighMerge Healthcare Recalls Merge LIS Software Due to Medication Display Error
FDA (Devices) · 2020-11-04
- ModerateMerge PACS Software Recall for Annotation Display Defect
FDA (Devices) · 2016-08-10