Merge Healthcare, Inc.: Medical Device Recall in 2017 - (Recall #: Z-2591-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

Merge PACS software. 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: May 8, 2017

Date Posted: June 21, 2017

Recall Number: Z-2591-2017

Event ID: 77249

Reason for Recall:

When cut lines are shown on an image, the lines may go from being vertical and then shift to horizontal causing confusion to the physician. This may cause a misdiagnosis.

Status: Terminated

Product Quantity: 47 sites have the potentially affected versions

Code Information:

Versions 7.0.2.1, 7.0.2.2, 7.0.2.3, 7.0.2.3 P1, and 7.0.2.3 P2

Distribution Pattern:

Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated