RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.
Reported: August 31, 2016 Initiated: January 31, 2016 #Z-2627-2016
Product Description
RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.
Reason for Recall
Potential for RadSuite AV viewer to skip image slices when the user presses page up or page down when the viewer displays multiple viewports and the user has mouse focused on any viewport other than the first viewport.
Details
- Recalling Firm
- Merge Healthcare, Inc.
- Units Affected
- 25 sites potentially have the affected versions
- Distribution
- Distribution was made to AL, AZ, CA, IL, MD, MA, MI, MO, NV, NJ, NC, OH, PA, TN, and VA. Government distribution was made to OK. There was no foreign/military distribution.
- Location
- Hartland, WI
Frequently Asked Questions
What product was recalled? ▼
RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.. Recalled by Merge Healthcare, Inc.. Units affected: 25 sites potentially have the affected versions.
Why was this product recalled? ▼
Potential for RadSuite AV viewer to skip image slices when the user presses page up or page down when the viewer displays multiple viewports and the user has mouse focused on any viewport other than the first viewport.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 31, 2016. Severity: Moderate. Recall number: Z-2627-2016.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11