RecallRadar

FDA Device recall Z-1457-2017

Merge Hemo software

On 2017-03-22 the FDA classified a Class II recall of Merge Hemo software by Merge Healthcare, citing in some instances, the system will lock tabs within a study, even when a second user does not have the study open on a different workstation.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1457-2017
ClassificationClass II
Statusterminated
Initiated2016-04-04
Published2017-03-22
Last updated2026-09-13 11:54 UTC
CompanyMerge Healthcare
DistributionUS

Product

Merge Hemo software. Product Usage: Merge Hemo is a hemodynamic monitoring system that records and displays physiological data.

Reason

In some instances, the system will lock tabs within a study, even when a second user does not have the study open on a different workstation.

Identifiers

code_infoVersions 6.10, 6.10.1, 6.10.2, 6.10.3, 7.10, 7.20, 7.20.1, 8.10.0, 8.20, 9.10.0, 9.20, 9.20.2, 9.20.3, 9.30, 9.40, 9.40.1, 9.40.2, and 9.40.3

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1457-2017%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.