Merge Healthcare, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0599-2017)

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:

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.

Product Classification:

Class II

Date Initiated: March 28, 2016

Date Posted: November 23, 2016

Recall Number: Z-0599-2017

Event ID: 75629

Reason for Recall:

The software did not show unviewed images when the last view was skipped. The physician may potentially misdiagnose when not all images are available for viewing.

Status: Terminated

Product Quantity: 534 sites potentially have the affected versions

Code Information:

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, 6.0 MR4, 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, 6.2.1, 6.2.2, 6.2.3, 6.2.4, 6.2.5, 6.3, 6.4, 6.4.1, 6.4.2, 6.4.3, 6.4.4, 6.4.5, 6.4.6, 6.4.7, 6.5, 6.5.5, 6.5.6, 6.5.7, 6.5.8, 6.5.9, 6.6, 6.6.1, 6.6.1.1, 6.6.2, 6.6.2.1, 6.6.2.2, 7.0, 7.0.1, and 7.0.2.

Distribution Pattern:

Worldwide Distribution - US Nationwide including Canada.

Voluntary or Mandated:

Voluntary: Firm initiated