Merge Eye Station Import Utility (ESIU). The firm name on the labeling is Merge Healthcare.
Reported: March 29, 2017 Initiated: April 4, 2016 #Z-1498-2017
Product Description
Merge Eye Station Import Utility (ESIU). The firm name on the labeling is Merge Healthcare.
Reason for Recall
System locks up which may result in potential patient injury or delay in diagnosis or treatment.
Details
- Recalling Firm
- Merge Healthcare, Inc.
- Units Affected
- 78 sites potentially have the affected accessory
- Distribution
- Distribution was made USA (nationwide) to medical facilities. Government distribution was made. Foreign distribution was made to Canada. There was no military distribution.
- Location
- Hartland, WI
Frequently Asked Questions
What product was recalled? ▼
Merge Eye Station Import Utility (ESIU). The firm name on the labeling is Merge Healthcare.. Recalled by Merge Healthcare, Inc.. Units affected: 78 sites potentially have the affected accessory.
Why was this product recalled? ▼
System locks up which may result in potential patient injury or delay in diagnosis or treatment.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 29, 2017. Severity: Moderate. Recall number: Z-1498-2017.
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