Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI.
Reported: February 15, 2017 Initiated: April 4, 2016 #Z-1176-2017
Product Description
Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI.
Reason for Recall
Potential exists for an incorrect patient image being displayed which could result in the delay in diagnosis or treatment.
Details
- Recalling Firm
- Merge Healthcare, Inc.
- Units Affected
- 29 sites have the potentially affected software
- Distribution
- Distribution was made to medical facilities in AZ, CA, CO, FL, HI, IL, MA, MD, MI, MO, NY, OH, PA, SC, TN, UT, and WI. There was no foreign/government/military distribution.
- Location
- Hartland, WI
Frequently Asked Questions
What product was recalled? ▼
Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI.. Recalled by Merge Healthcare, Inc.. Units affected: 29 sites have the potentially affected software.
Why was this product recalled? ▼
Potential exists for an incorrect patient image being displayed which could result in the delay in diagnosis or treatment.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 15, 2017. Severity: Moderate. Recall number: Z-1176-2017.
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