Merge Healthcare, Inc.: Medical Device Recall in 2016 - (Recall #: Z-2796-2016)

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: May 6, 2013

Date Posted: September 21, 2016

Recall Number: Z-2796-2016

Event ID: 74815

Reason for Recall:

Multiple studies were missing at a customer location that never made it to the archive before watermarking

Status: Terminated

Product Quantity: 45 sites potentially have the affected versions

Code Information:

This potential patient safety issue is only present in the following versions when a reverse workflow is used: 2004-R6.x, 5.10.x, 5.20, 5.25, 5.30.1, 5.30.2, 5.30.2 SB0344, 5.30.3, 5.30.4, 5.30.4 HF0418E, 5.30.5, 5.30.5 HF0404E, 5.30.5 HF0413E, 5.30.5 HF390E, 5.30.5 SB0368, 5.30.6, 5.30.6 HF0405E, 5.30.6 HF0406E, 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, 5.35.4 HF0513, 5.35.4 HF0518, 5.35.4 HF0528, 5.35.4 HF0531, 5.35.4 HF0535, 5.35.4 HF0546, 8.30.0. NOTE: The standard workflow is not impacted. .

Distribution Pattern:

Distribution was nationwide to medical facilities. Government distribution was made to LA and OK.

Voluntary or Mandated:

Voluntary: Firm initiated