RecallRadar

FDA Device recall Z-1498-2017

Merge Eye Station Import Utility (ESIU). The firm name on the labeling is Merge Healthcare

On 2017-03-29 the FDA classified a Class II recall of Merge Eye Station Import Utility (ESIU). The firm name on the labeling is Merge Healthcare by Merge Healthcare, citing system locks up which may result in potential patient injury or delay in diagnosis or treatment.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1498-2017
ClassificationClass II
Statusterminated
Initiated2016-04-04
Published2017-03-29
Last updated2026-09-13 11:54 UTC
CompanyMerge Healthcare
DistributionUS

Product

Merge Eye Station Import Utility (ESIU). The firm name on the labeling is Merge Healthcare.

Reason

System locks up which may result in potential patient injury or delay in diagnosis or treatment.

Identifiers

code_infoVersions 1.1.2 and 1.1.3

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-1498-2017%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.