Merge Healthcare, Inc.: Medical Device Recall in 2016 - (Recall #: Z-2627-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.

Product Classification:

Class II

Date Initiated: January 31, 2016

Date Posted: August 31, 2016

Recall Number: Z-2627-2016

Event ID: 74919

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.

Status: Terminated

Product Quantity: 25 sites potentially have the affected versions

Code Information:

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, 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, 5.35.3, 5.35.4, and 5.35.4 HF0513

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated