RecallRadar

FDA Device recall Z-0611-2017

iConnect Access software

On 2016-11-23 the FDA classified a Class II recall of iConnect Access software by Merge Healthcare, citing software displayed incorrect prior reports in the viewport area, only when more than one prior study (2 or more) was viewed.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0611-2017
ClassificationClass II
Statusterminated
Initiated2016-05-25
Published2016-11-23
Last updated2026-09-13 11:54 UTC
CompanyMerge Healthcare
DistributionUS

Product

iConnect Access software. The firm name on the label is Merge Healthcare, Hartland, WI.

Reason

Software displayed incorrect prior reports in the viewport area, only when more than one prior study (2 or more) was viewed.

Identifiers

code_infoVersions 3.0.1, 3.1, and 3.2

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-0611-2017%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.