Centricity Universal Viewer 6.0, a device that displays medical images and data from various imaging sources, and from other healthcare information sources.
Reported: January 29, 2020 Initiated: December 16, 2019 #Z-0819-2020
Product Description
Centricity Universal Viewer 6.0, a device that displays medical images and data from various imaging sources, and from other healthcare information sources.
Reason for Recall
Centricity Universal Viewer measurements saved into a DICOM Grayscale Presentation State are incorrect in subsequent views for exams containing series with different pixel sizes and may lead to a potential misdiagnosis.
Details
- Recalling Firm
- GE Healthcare, LLC
- Units Affected
- 205
- Distribution
- Distributed nationwide; Internationally distributed to Mexico and 24 additional countries.
- Location
- Waukesha, WI
Frequently Asked Questions
What product was recalled? ▼
Centricity Universal Viewer 6.0, a device that displays medical images and data from various imaging sources, and from other healthcare information sources.. Recalled by GE Healthcare, LLC. Units affected: 205.
Why was this product recalled? ▼
Centricity Universal Viewer measurements saved into a DICOM Grayscale Presentation State are incorrect in subsequent views for exams containing series with different pixel sizes and may lead to a potential misdiagnosis.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 29, 2020. Severity: Moderate. Recall number: Z-0819-2020.
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