Class II Recall

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

Summary

The FDA issued a Class II for GE Vscan Extend, being sold as "Vscan Extend Sector USB" by GE Healthcare, LLC. 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 batter.

Details

Source

Device Recall

External ID

Z-0523-2022

Action Date

2022-02-02

Status

Ongoing

Product Description

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

Lot/Code Info: Information reads "Serial Number (UDI, Model Number)". VH150315TI (01008406821216511118020021VH150315TI, H41212RR), VH15019235 (01008406821216511117033021VH15019235, H41212RR), VH150328FJ (01008406821216511118021321VH150328FJ, H41212RR), VH1503146U (01008406821216511118020921VH1503146U, H41212RR), VH1503356H (01008406821216511118021321VH1503356H, H41212RR), VH150318PI (01008406821216511118020821VH150318PI, H41212RR), VH2006357M (01008406821216511121031721VH2006357M, H41212ZB), VH1505402S (01008406821216511118120021VH1505402S, H41212ZB), VH150277MA (01008406821216511117100021VH150277MA, H41212RR), VH150278XK (01008406821216511119030221VH150278XK, H41212ZB), VH150280EN (01008406821216511117100021VH150280EN, H41212RR), VH15028191 (01008406821216511117100021VH15028191, H41212RR), VH150282CY (01008406821216511117100021VH150282CY, H41212RR), VH150283L3 (01008406821216511117100021VH150283L3, H41212RR), VH150296YP (01008406821216511118010021VH150296YP, H41212RR), VH150298DQ (01008406821216511118010021VH150298DQ, H41212RR), VH150299RZ (01008406821216511118010021VH150299RZ, H41212RR), VH15030049 (01008406821216511118010021VH15030049, H41212RR), VH150301JU (01008406821216511118010021VH150301JU, H41212RR), VH150305E7 (01008406821216511118020021VH150305E7, H41212RR), VH150325R6 (01008406821216511118020021VH150325R6, H41212RR), VH150332EL (01008406821216511118020021VH150332EL, H41212RR), VH150334AV (01008406821216511118020021VH150334AV, H41212RR), VH150356RI (01008406821216511118020021VH150356RI, H41212RR), VH150369TF (01008406821216511118020021VH150369TF, H41212RR), VH150396VW (01008406821216511118050021VH150396VW, H41212ZB), VH150398X2 (01008406821216511118050021VH150398X2, H41212ZB), VH1504078Q (01008406821216511118060021VH1504078Q, H41212ZB), VH150413SH (01008406821216511118060021VH150413SH, H41212ZB), VH1504145M (01008406821216511118060021VH1504145M, H41212ZB), VH150418YP (01008406821216511118060021VH150418YP, H41212ZB), VH15041959 (01008406821216511118110021VH15041959, H41212ZB), VH150498S4 (01008406821216511118110021VH150498S4, H41212ZB), VH1505015I (01008406821216511118110021VH1505015I, H41212ZB), VH1505026L (01008406821216511118110021VH1505026L, H41212ZB), VH150503FG (01008406821216511118110021VH150503FG, H41212ZB), VH150504PC (01008406821216511118110021VH150504PC, H41212ZB), VH150505WS (01008406821216511118110021VH150505WS, H41212ZB), VH150541JB (01008406821216511118120021VH150541JB, H41212ZB), VH150599H5 (01008406821216511119010021VH150599H5, H41212ZB), VH150603Q1 (01008406821216511119010021VH150603Q1, H41212ZB), VH1506321L (01008406821216511119030421VH1506321L, H41212ZB), VH150635LI (01008406821216511119030421VH150635LI, H41212ZB), VH150667SK (01008406821216511119040321VH150667SK, H41212ZB), VH150672TF (01008406821216511119040021VH150672TF, H41212ZB), VH150787F1 (01008406821216511119040021VH150787F1, H41212ZB), VH150788JE (01008406821216511119040021VH150788JE, H41212ZB), VH1503213I (01008406821216511118020021VH1503213I, H41212RR), VH150804V1 (01008406821216511119040021VH150804V1, H41212ZB), VH1506815J (01008406821216511119040021VH1506815J, H41212ZB), VH150409WM (01008406821216511118060021VH150409WM, H41212ZB), VH150753TC (01008406821216511119040421VH150753TC, H41212ZB), VH150421I5 (01008406821216511118080021VH150421I5, H41212ZB), VH200797WX (01008406821216511121090221VH200797WX, H41212ZB), VH150766CY (01008406821216511119050021VH150766CY, H41212ZB), VH20076196 (01008406821216511121090221VH20076196, H41212ZB), VH150520G8 (01008406821216511118120021VH150520G8, H41212ZB), VH2003248W (01008406821216511120091621VH2003248W, H41212ZB), VH150614LJ (01008406821216511119010021VH150614LJ, H41212ZB), VH1508428Q (01008406821216511119050021VH1508428Q, H41212ZB), VH200338JV (01008406821216511120091621VH200338JV, H41212ZB), VH1501821N (01008406821216511117030021VH1501821N, H41212RR), VH200729TM (01008406821216511121080521VH200729TM, H41212ZB)

Quantity Affected: 12,526 total reported units (61 units of this model)

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.

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.

Type: Voluntary: Firm initiated

Recall Initiated: 2021-11-04

Company

GE Healthcare, LLC

Waukesha, WI

Context & Analysis

This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.

This was one of 97 device recalls issued in the same week, part of 413 device-related FDA actions this month.

GE Healthcare, LLC has 104 FDA actions in our database, including 104 recalls.

Frequently Asked Questions

What is a Class II recall?

A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (GE Healthcare, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does GE Healthcare, LLC have FDA actions?

GE Healthcare, LLC has 104 FDA actions in our database, including 104 recalls and 0 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "Z-0523-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

Want to know the moment something like this happens?

Get alerts for device

Related Actions

MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200

Covidien LP · 2023-08-23

Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINO

MEDLINE INDUSTRIES, LP - Northfield · 2023-02-15

VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the uri

Boston Scientific Corporation · 2024-09-25

EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoo

Enchroma Inc · 2024-11-27

Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;

Adept Medical Ltd · 2025-01-29