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

FDA device recall Z-0522-2022 · posted 2022-01-24 · Open, Classified

Recall details

Recalling firm

GE Healthcare, LLC

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.

Action taken

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 connect the device to AC power when it is connected to a PC, and if the device is being used outside of a normal hospital or clinic setting where it is the only imaging device available, ensure the device functionality is checked daily or before each shift. Attached to the notification was an Acknowledgment Response form that was to be returned by email within 30 days of receipt of the notice. Customers with any questions are to contact GE Healthcare Service at 1-800-437-1171 or their local Service Representative.

Root cause

Device Design

Status

Open, Classified

Product code

IYO

Quantity 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

Date initiated

2021-11-04

Date posted

2022-01-24

Location

Waukesha, WI

Related 510(k) clearances