FDA recall Z-0819-2020

Product

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.

Distribution

Distributed nationwide; Internationally distributed to Mexico and 24 additional countries.

Key facts

Status

Terminated

Initiation date

2019-12-16

Report date

2020-01-29

Termination date

2023-10-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Waukesha, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0819-2020