Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.
Reported: August 10, 2016 Initiated: January 30, 2016 #Z-2301-2016
Product Description
Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.
Reason for Recall
Studies coming over via telmed were missing patient's DOB, procedure, and referring physician.
Details
- Recalling Firm
- Merge Healthcare, Inc.
- Units Affected
- 109 sites have the affected versions
- Distribution
- Worldwide Distribution -- USA, New Zealand, and United Kingdom.
- Location
- Hartland, WI
Frequently Asked Questions
What product was recalled? ▼
Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.. Recalled by Merge Healthcare, Inc.. Units affected: 109 sites have the affected versions.
Why was this product recalled? ▼
Studies coming over via telmed were missing patient's DOB, procedure, and referring physician.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 10, 2016. Severity: Moderate. Recall number: Z-2301-2016.
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