Agency classClass IIOur severity:High FDA (Devices)·Z-0599-2017·Announced 2016-11-23

Merge PACS software recall due to unviewed image display defect

Merge Healthcare is recalling Merge PACS software because it may fail to display unviewed images, potentially leading to physician misdiagnosis.

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 risk-of-harm product (medical imaging software) where injury (misdiagnosis) has not yet been reported, fitting the High severity criteria.

Plain-English summary

Merge Healthcare, Inc. is recalling Merge PACS (Picture Archiving Communication System) software. The software is designed for soft copy reading, communication, and storage of studies produced by digital modalities, including digital mammography.

The recall is due to a defect where the software did not show unviewed images when the last view was skipped. This issue means that not all images may be available for viewing, which could potentially lead to a physician misdiagnosing a patient.

Approximately 534 sites potentially have the affected versions. The software was distributed worldwide, including the United States and Canada. Affected versions include V6.0 MR2 through 7.0.2. Users should contact Merge Healthcare for instructions on how to resolve the issue.

The recalled product

Product: Merge PACS software. Product Usage: Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading, communication and storage of studies produced by digital modalities, including digital mammography.
Manufacturer: Merge Healthcare, Inc.
Category: Medical Device — Software
Hazard: misdiagnosis
software-defect
Affected units: 534

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 (20)

Versions: V6.0 MR2
6.0 MR3
6.0 MR3 CU
6.0 MR4
6.0 MR4 CU1
6.0 MR4 CU2
6.0 MR4 CU3
6.0 MR4 CU4
6.0 MR4 CU5
6.0 MR4 CU6
CU7
6.0 MR4 CU8
6.0 MR4 CU9
6.0 MR4 CU10
6.0 MR4 CU11
6.1
6.1.1
6.1.2
6.1.3
6.2

Distribution

Distributed nationwide across the United States.

Same manufacturer · Merge Healthcare, Inc.

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