PlainRecalls
FDA Devices Moderate Class II Terminated

Centricity Universal Viewer with PACS-IW foundation 6.0, Model number 2090255-001 Product Usage: Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image inte

Reported: July 3, 2019 Initiated: May 17, 2019 #Z-1886-2019

Product Description

Centricity Universal Viewer with PACS-IW foundation 6.0, Model number 2090255-001 Product Usage: Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Megapixel resolution and meet other technical specifications reviewed and accepted by the FDA.

Reason for Recall

There is a potential that one or more images or image series may be missing from exams without a warning displayed in the viewer.

Details

Recalling Firm
GE Healthcare, LLC
Units Affected
292 units
Distribution
Worldwide Distribution - US Nationwide Austria, Belgium, Brazil Canada Colombia France Germany Ghana India Ireland Israel Italy Kuwait Mexico Netherlands Panama Poland Qatar Russia Saudi Arabia Slovenia South Africa Spain Switzerland Turkey United Arab Emirates United Kingdom Uruguay
Location
Waukesha, WI

Frequently Asked Questions

What product was recalled? ▼
Centricity Universal Viewer with PACS-IW foundation 6.0, Model number 2090255-001 Product Usage: Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Megapixel resolution and meet other technical specifications reviewed and accepted by the FDA.. Recalled by GE Healthcare, LLC. Units affected: 292 units.
Why was this product recalled? ▼
There is a potential that one or more images or image series may be missing from exams without a warning displayed in the viewer.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 3, 2019. Severity: Moderate. Recall number: Z-1886-2019.

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