Merge Healthcare Recalls RadSuite Software Due to Image Display Error
Merge Healthcare is recalling RadSuite software versions 5.30 and 5.35 because the viewer may skip image slices when navigating with multiple viewports.
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, and the hazard involves a risk of harm (skipping image slices) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Merge Healthcare, Inc. is recalling specific versions of RadSuite software. The recall involves versions 5.30.7 through 5.35.4, including various hotfixes and service packs. The software is used for medical imaging and is distributed to sites in 16 U.S. states and the government sector in Oklahoma.
The recall is due to a potential defect in the RadSuite AV viewer. When the viewer displays multiple viewports and the user has the mouse focused on any viewport other than the first, pressing the page up or page down keys may cause the software to skip image slices. This could result in incomplete viewing of the medical images.
Approximately 25 sites potentially have the affected versions. Distribution was made to Alabama, Arizona, California, Illinois, Maryland, Massachusetts, Michigan, Missouri, Nevada, New Jersey, North Carolina, Ohio, Pennsylvania, Tennessee, and Virginia. Government distribution was made to Oklahoma. There was no foreign or military distribution. Users should contact Merge Healthcare for instructions on how to resolve the issue.
The recalled product
- Product
- RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.
- Manufacturer
- Merge Healthcare, Inc.
- Category
- Medical Device — Software
- Affected units
- 25
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: 5.30.7
- 5.30.7 HF0429E
- 5.30.7 HF0441E
- 5.30.7 HF0446E
- 5.30.7 HF0470E
- 5.30.7 HF0473E
- 5.30.8
- 5.30.8 HF0477E
- 5.30.8 HF0490E
- 5.30.8 HF0495 SB0508E
- 5.30.8 HF0495E
- SB504E
- 5.30.8 HF0550
- 5.30.8 SB0485E
- 5.30.8 SB0486E
- 5.30.X SB0381E
- 5.35.1
- 5.35.1 HF0487E
- 5.35.1 HF0489E
- 5.35.2
Distribution
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