Recall Z-0519-2022 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
GE Healthcare, LLC
GE Vscan Extend, being sold as "Vscan Extend Dual DICOM"
| Date | Jan 24, 2022 (initiated Nov 4, 2021) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| Action | The firm distributed an Urgent Medical Device Correction letter to customers on 11/17/2021 informing customers of the issue with Vscan Extend devices not powering on because of depleted internal battery. This issue occurs if the device is not turned off prior to the external battery being removed or when the device is connected to a personal computer without connecting to AC power. The actions needed to be taken by the user until a software update could be deployed were identified in this notice as: make sure to power off the Vscan Extend device before removing the external battery, always con |
| Quantity | 12,526 total reported units (9,771 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, Braz |
| FDA record | Open on fda.gov |