Merge PACS Software Recalled for Incorrect MPR Measurements
Merge Healthcare is recalling Merge PACS software because multiplanar reformation (MPR) measurements may be incorrect.
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 is classified as FDA Class II. While the source does not explicitly state 'no injuries reported,' it describes a functional defect (incorrect measurements) without citing specific injury reports or hospitalizations, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported or is theoretical.
Plain-English summary
Merge Healthcare, Inc. is recalling 125 units of Merge PACS software. The recall involves specific versions of the software, including v8.1, v81.1, and V8.1.2, which are identified by specific Unique Device Identifiers (UDIs) listed in the recall notice.
The reason for the recall is that measurements generated on Multiplanar Reformation (MPR) images may be incorrect. This software is distributed domestically across numerous U.S. states, including Illinois, Missouri, New York, and California, as well as internationally in Belgium and the United Kingdom.
Healthcare facilities and users of this software should contact Merge Healthcare for instructions on how to address the issue. The recall is classified as Class II by the FDA, indicating that use of the product could, in some cases, cause temporary or medically reversible health consequences.
The recalled product
- Product
- Merge PACS
- Manufacturer
- Merge Healthcare, Inc.
- Category
- Medical Device — Software
- Hazard
- Affected units
- 125
Distribution
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