PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: April 19, 2017 Initiated: March 10, 2017 #Z-1780-2017

Product Description

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

Reason for Recall

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.

Details

Recalling Firm
GE Healthcare, LLC
Units Affected
396 (67 US; 329 OUS)
Distribution
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
Location
Waukesha, WI

Frequently Asked Questions

What product was recalled? ▼
Vivid S60/S70/S60N/S70N, H45041SU, H45041SW, H45581MS, H45581PD.. Recalled by GE Healthcare, LLC. Units affected: 396 (67 US; 329 OUS).
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 19, 2017. Severity: Moderate. Recall number: Z-1780-2017.

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