GE Healthcare, LLC recalls Vivid S60/S70/S60N/S70N, H45041SU, H45041SW, H45581MS, H45581PD.

Recall date

March 10, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1780-2017

FDA classification

Class II

Brand / firm

GE Healthcare, LLC

Sold / distributed

United Kingdom, United Arab Emirates, Turkey, Thailand, Switzerland, Sweden, Spain, South Africa, Slovenia, Saudi Arabia, Russia, Romania, Portugal, Poland, Philippines, Norway, New Zealand, New Caledonia, Netherlands, Myanmar, Kuwait, Korea (Republic of), Japan, Italy, ISRAEL, Ireland, Iran, India…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Vivid S60/S70/S60N/S70N, H45041SU, H45041SW, H45581MS, H45581PD.