Recall Z-2944-2020— Merge Healthcare, Inc.

Name: FDA recall Z-2944-2020
Creator: U.S. Food and Drug Administration
Published: 2020-08-06

Class II · Terminated

Class II FDA medical device recall by Merge Healthcare, Inc., initiated 2020-08-06, terminated 2022-11-30. It names one FDA 510(k) clearance: K192455. Product: Merge PACS. Reason: Measurements done on the Merge PACS generated MPR s may have incorrect measurements..

Recalling firm: Merge Healthcare, Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-08-06
Terminated: 2022-11-30
Firm location: Hartland, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K192455 — Merge PACSMerge Healthcare Incorporated·cleared 2019-10-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Merge PACS

Reason for recall

Measurements done on the Merge PACS generated MPR s may have incorrect measurements.

Data sourced from openFDA. This site is unofficial and independent of the FDA.