FDA Devices Moderate Class II Ongoing

GE Vscan Extend, being sold as "Vscan Extend Sector DICOM"

Reported: February 2, 2022 Initiated: November 4, 2021 #Z-0522-2022

Product Description

Reason for Recall

The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a computer without AC power.

Details

Recalling Firm: GE Healthcare, LLC
Units Affected: 12,526 total reported units (1,451 units of this model)
Distribution: Domestic: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT. NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, PR, and DC. International: Albania, Australia, Austria, Bahrain, Bangladesh, Belgium, Bosnia, Brazil, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Dubai, Ecuador, El Salvador, Estonia, Fiji, Finland, France, Germany, Greece, Haiti, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Korea, Kuwait, Lebanon, Lithuania, Malaysia, Malta, Mexico, Moldova, Morocco, Myanmar, Netherlands, New Zealand, Norway, Papua New Guinea, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, Somalia, South Africa, Spain, Sweden, Switzerland, Thailand, Togo, Trinidad and Tobago, Turkey, Ukraine, United Arab Emirates, United Kingdom, Vietnam, and Western Sahara.
Location: Waukesha, WI

Frequently Asked Questions

What product was recalled? ▼

GE Vscan Extend, being sold as "Vscan Extend Sector DICOM". Recalled by GE Healthcare, LLC. Units affected: 12,526 total reported units (1,451 units of this model).

Why was this product recalled? ▼

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on February 2, 2022. Severity: Moderate. Recall number: Z-0522-2022.