RecallRadar

FDA Device recall Z-1496-2017

Merge Cardio software with Issuer of Patient ID (IPID). The firm name on the label is Merge Healthcare, Hartland, WI

On 2017-03-29 the FDA classified a Class II recall of Merge Cardio software with Issuer of Patient ID (IPID). The firm name on the label is Merge Healthcare, Hartland, WI by Merge Healthcare, citing for sites using the Issuer of Patient ID (IPID), the system will display the study list and images from different patients with different IPIDs as though they are for the same pat….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1496-2017
ClassificationClass II
Statusterminated
Initiated2015-09-22
Published2017-03-29
Last updated2026-09-13 11:54 UTC
CompanyMerge Healthcare
DistributionGA, IL, MD, MI, MO, OH, TN, VT

Product

Merge Cardio software with Issuer of Patient ID (IPID). The firm name on the label is Merge Healthcare, Hartland, WI.

Reason

For sites using the Issuer of Patient ID (IPID), the system will display the study list and images from different patients with different IPIDs as though they are for the same patient if they all have the first name, last name, and medical record number in common.

Identifiers

code_infoVersions 8.30, 9.0, 9.0.1, 9.0.2, 9.0.3, 9.0.4, 9.0.5, 9.0.6, 9.0.7, 9.0.8, 10.0, 10.0.1, and 10.1 with Issuer of Patient ID (IPID)

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-1496-2017%22

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