Data Foundry

Medical device recalls 2017

Merge Cardio software with Issuer of Patient ID — Class II medical device recall Z-1496-2017

Terminated recall by Merge Healthcare, Inc., reported 2017-03-29, distributed in GA, IL, MD, MI, MO, OH, TN, VT. For sites using the Issuer of Patient ID (IPID), the system will display the study list and images from differ

Recall numberZ-1496-2017
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmMerge Healthcare, Inc., Hartland, WI, United States
Recall initiated2015-09-22
Classified2017-03-20
Reported by FDA2017-03-29
Terminated2017-04-18
DistributedGA, IL, MD, MI, MO, OH, TN, VT
Quantity16 sites

Product

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

Reason for recall

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1496-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.