Merge PACS software recalled due to patient name mismatch
Merge Healthcare is recalling PACS software versions V6.0.2.0 MR2 and earlier because patient names in the interface do not match the displayed images.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device software defect that poses a risk of harm through patient misidentification, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Merge Healthcare, Inc. is recalling Merge PACS software, versions V6.0.2.0 MR2 and earlier. The software was distributed under the AMICAS label in Brighton, MA, before the labeling was changed to Merge Healthcare in Hartland, WI.
The recall is due to a software defect where the patient name displayed in the Halo title bar and thumbnails does not match the name on the displayed images. This discrepancy could lead to confusion regarding patient identity during image review.
The affected software was distributed to medical facilities nationwide, with government distribution to Minnesota and foreign distribution to Australia and the United Kingdom. There was no military distribution. A total of 93 sites have the affected version. Consumers and medical facilities should contact Merge Healthcare for further instructions on resolving this issue.
The recalled product
- Product
- Merge PACS software. Product was distributed under the AMICAS label, Brighton, MA, but labeling was later changed to Merge Healthcare, Hartland, WI.
- Manufacturer
- Merge Healthcare, Inc.
- Category
- Medical Device — PACS Software
- Affected units
- 93
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)
- Versions: V6.0.2.0 MR2 and earlier
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 · mis labeling
See all →- SevereImperio Distribution Recalls Beef Jerky Produced Without Federal Inspection
USDA FSIS · 2026-10-24
- HighJ K Patisserie Chocolate Chip Cookies Recalled for Undeclared Soy
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
Similar recalls
- 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 PACS software recall for inconsistent mammography lesion measurements
FDA (Devices) · 2016-08-17
- ModerateMerge PACS Software Recall for Annotation Display Defect
FDA (Devices) · 2016-08-10
- ModerateMerge PACS software recall for missing patient data in telmed studies
FDA (Devices) · 2016-08-10
- ModerateMerge Healthcare Recalls OfficePACS Software Due to Data Loss Risk
FDA (Devices) · 2016-07-20