medical MODERATE Updated 2017-03-29

Merge Healthcare, Inc. recalls Merge Cardio software with Issuer of Patient ID (IPID). The

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Recalled Product

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

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Hazard / Issue

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.

Issued by

FDA

Affected States: GA, IL, MD, MI, MO, OH, TN, VT
Lot/Code Info: Versions 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)

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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View official government recall