medical MODERATE Updated 2017-03-29

Merge Healthcare, Inc. recalls Merge Cardio software using EchoIMS. The firm name on the l

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Recalled Product

Merge Cardio software using EchoIMS. The firm name on the label is Merge Healthcare, Hartland, WI.

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Hazard / Issue

A situation can occur allowing two physicians to access the same study report in EchoIMS when launched from the Cardio Study List without receiving the read-only notification prompt.

Issued by

FDA

Affected States: CA, FL, IL, MD, MO, OH, OK, TX, VT, WI
Lot/Code Info: Version 9.0.9 and earlier using EchoIMS.

✅ 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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