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GE Healthcare, LLC recalls Vivid S60/S70/S60N/S70N, H45041SU, H45041SW, H45581MS, H45581PD.
Recalled April 19, 2017 · FDA recall Z-1780-2017 · GE Healthcare
Hazard
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. · FDA Class II
Units
396 (67 US; 329 OUS)
Sold at
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, Hungary, Hong Kong, Guatemala, Greece, Great Britain, Germany, France, Finland, Estonia, Egypt, Ecuador, Denmark, Czech Republic, Croatia, Colombia, Chile, Canada, Bulgaria, Brunei Darussalam, Brazil, Belgium, Austria, Australia, Argentina, Vietnam. Uruguay, Taiwan, Slovakia, Singapore, Reunion, Qatar, Panama, Pakistan, Jordan, Indonesia, Guadeloupe, Czech Republic
Description
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.
Product
Vivid S60/S70/S60N/S70N, H45041SU, H45041SW, H45581MS, H45581PD.
Manufacturer(s)
GE Healthcare, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →