Merge Cardio software using EchoIMS. The firm name on the label is Merge Healthcare, Hartland, WI.
Reported: March 29, 2017 Initiated: April 4, 2016 #Z-1415-2017
Product Description
Merge Cardio software using EchoIMS. The firm name on the label is Merge Healthcare, Hartland, WI.
Reason for Recall
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.
Details
- Recalling Firm
- Merge Healthcare, Inc.
- Units Affected
- 17 sites potentially have the affected versions
- Distribution
- US Distribution was made to medical facilities in CA, FL, IL, MD, MO, OH, OK, TX, VT, and WI. Military distribution was also made.
- Location
- Hartland, WI
Frequently Asked Questions
What product was recalled? ▼
Merge Cardio software using EchoIMS. The firm name on the label is Merge Healthcare, Hartland, WI.. Recalled by Merge Healthcare, Inc.. Units affected: 17 sites potentially have the affected versions.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 29, 2017. Severity: Moderate. Recall number: Z-1415-2017.
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