Merge Cardio software with Issuer of Patient ID (IPID). The firm name on the label is Merge Healthcare, Hartland, WI.
Reported: March 29, 2017 Initiated: September 22, 2015 #Z-1496-2017
Product Description
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.
Details
- Recalling Firm
- Merge Healthcare, Inc.
- Units Affected
- 16 sites were originally identified as potentially having the affected versions
- Distribution
- US Distribution was made to medical facilities located in GA, IL, MD, MI, MO, OH, TN, and VT. There was no foreign/government/military distribution.
- Location
- Hartland, WI
Frequently Asked Questions
What product was recalled? ▼
Merge Cardio software with Issuer of Patient ID (IPID). The firm name on the label is Merge Healthcare, Hartland, WI.. Recalled by Merge Healthcare, Inc.. Units affected: 16 sites were originally identified as potentially having the affected versions.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 29, 2017. Severity: Moderate. Recall number: Z-1496-2017.
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