19

Apr

2017

GE Vivid Cl II

0

Company:GE Healthcare, LLC
Date of Enforcement Report 4/192017
Class lI:

PRODUCT

1. Vivid E95/E90/E80, H45581DC, H45581LB and H45581DA.
Recall Number Z-1779-2017
2. Vivid S60/S70/S60N/S70N, H45041SU, H45041SW, H45581MS, H45581PD.
Recall Number Z-1779-2017

REASON
GE Healthcare has become aware of an issue where a patient other than the intended is incorrectly selected by the operator in situations where DICOM Worklist search response time is slow. This issue is limited to certain Vivid Ultrasound systems and can result in the incorrect patient information showing on the screen during the exam. If not detected by the operator, images from the actual (intended) patient will be stored under the incorrect patient after the exam. This issue could lead to misdiagnosis. There have been no injuries reported because of this issue.

RECALLING FIRM/MANUFACTURER
GE Healthcare, LLC, Waukesha, WI on 3/10/2017. Voluntary: Firm Initiated recall is ongling.

VOLUME OF PRODUCT IN COMMERCE
1. 971(412 US; 559 OUS)
2. 396 (67 US; 329 OUS)

DISTRIBUTION
Nationwide and Internationally

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About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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