Z-0520-2022Class II

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

Name: Z-0520-2022 GE Vscan Extend, being sold as "Vscan Extend Dual USB"
Creator: GE Healthcare, LLC
Published: 2021-11-04
License: https://open.fda.gov/license/

GE Healthcare / initiated 2021-11-04 / Open, Classified / root cause: design

FDA source

GE Healthcare, LLC began a recall of GE Vscan Extend, being sold as "Vscan Extend Dual USB" on 2021-11-04. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0520-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-11-04
Posted: 2022-01-24
Recalling firm: GE Healthcare
Product: GE Vscan Extend, being sold as "Vscan Extend Dual USB"
Product code: IYO System, Imaging, Pulsed Echo, Ultrasonic
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.
Root cause tag: design
FDA 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 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.
Quantity in commerce: 12,526 total reported units (77 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.
Product codes and lots: Information reads "Serial Number (UDI, Model Nubmer)". VH1602482A (01008406821216511117040721VH1602482A, H41212RK), VH160398U2 (01008406821216511117040021VH160398U2, H41212RK), VH160910MS (01008406821216511117090021VH160910MS, H41212RK), VH160692PU (01008406821216511117060021VH160692PU, H41212RK), VH16072033 (01008406821216511117060021VH16072033, H41212RK), VH164639E1 (01008406821216511119060021VH164639E1, H41212YY), VH165023E4 (01008406821216511119090021VH165023E4, H41212YY), VH26557563 (01008406821216511121071221VH26557563, H41212YY), VH265583RM (01008406821216511121070921VH265583RM, H41212YY), VH2656017N (01008406821216511121070821VH2656017N, H41212YY), VH265638Q4 (01008406821216511121070921VH265638Q4, H41212YY), VH26564046 (01008406821216511121070921VH26564046, H41212YY), VH265645Q7 (01008406821216511121070821VH265645Q7, H41212YY), VH265647U2 (01008406821216511121070921VH265647U2, H41212YY), VH265836ZG (01008406821216511121071221VH265836ZG, H41212YY), VH265838JV (01008406821216511121071221VH265838JV, H41212YY), VH265842CE (01008406821216511121071221VH265842CE, H41212YY), VH265844SA (01008406821216511121070921VH265844SA, H41212YY), VH265845WV (01008406821216511121071221VH265845WV, H41212YY), VH265849MM (01008406821216511121070921VH265849MM, H41212YY), VH265851HS (01008406821216511121071221VH265851HS, H41212YY), VH26585212 (01008406821216511121070921VH26585212, H41212YY), VH265857ZW (01008406821216511121070921VH265857ZW, H41212YY), VH265858LY (01008406821216511121071221VH265858LY, H41212YY), VH265864P5 (01008406821216511121070921VH265864P5, H41212YY), VH1632681A (01008406821216511118100021VH1632681A, H41212YY), VH160462WV (01008406821216511117040021VH160462WV, H41212RK), VH160549FR (01008406821216511117060021VH160549FR, H41212RK), VH16055357 (01008406821216511117060021VH16055357, H41212RK), VH160673KV (01008406821216511117060021VH160673KV, H41212RK), VH160674YQ (01008406821216511117060021VH160674YQ, H41212RK), VH160717US (01008406821216511117060021VH160717US, H41212RK), VH160724UV (01008406821216511117110021VH160724UV, H41212RK), VH160844BL (01008406821216511117110021VH160844BL, H41212RK), VH160851T5 (01008406821216511117110021VH160851T5, H41212RK), VH160879LS (01008406821216511117090021VH160879LS, H41212RK), VH16090735 (01008406821216511117090021VH16090735, H41212RK), VH160911AW (01008406821216511117090021VH160911AW, H41212RK), VH16092049 (01008406821216511117090021VH16092049, H41212RK), VH160934IF (01008406821216511117090021VH160934IF, H41212RK), VH160940WS (01008406821216511117100021VH160940WS, H41212RK), VH160984TC (01008406821216511117100021VH160984TC, H41212RK), VH161007CG (01008406821216511117100021VH161007CG, H41212RK), VH161008JP (01008406821216511117100021VH161008JP, H41212RK), VH161028CS (01008406821216511117100021VH161028CS, H41212RK), VH1610527V (01008406821216511117100021VH1610527V, H41212RK), VH1610803G (01008406821216511117100021VH1610803G, H41212RK), VH161086VQ (01008406821216511117100021VH161086VQ, H41212RK), VH1610908L (01008406821216511117100021VH1610908L, H41212RK), VH16109229 (01008406821216511117100021VH16109229, H41212RK), VH161231L5 (01008406821216511117110021VH161231L5, H41212RK), VH161675YG (01008406821216511118030021VH161675YG, H41212RK), VH162475JG (01008406821216511118100021VH162475JG, H41212YY), VH162998CK (01008406821216511118100021VH162998CK, H41212YY), VH1630084S (01008406821216511118100021VH1630084S, H41212YY), VH1633236I (01008406821216511118110021VH1633236I, H41212YY), VH16065514 (01008406821216511117050021VH16065514, H41212RK), VH162006EW (01008406821216511118030021VH162006EW, H41212RK), VH165572VH (01008406821216511119080021VH165572VH, H41212YY), VH2631208T (01008406821216511120081721VH2631208T, H41212YY), VH263163KT (01008406821216511120081721VH263163KT, H41212YY), VH263287F8 (01008406821216511120081721VH263287F8, H41212YY), VH262239Y9 (01008406821216511120061221VH262239Y9, H41212YY), VH262110GZ (01008406821216511120060221VH262110GZ, H41212YY), VH262109PN (01008406821216511120060221VH262109PN, H41212YY), VH260405KN (01008406821216511119120021VH260405KN, H41212YY), VH261920X9 (01008406821216511120051821VH261920X9, H41212YY), VH263156PR (01008406821216511120091521VH263156PR, H41212YY), VH262014IC (01008406821216511120060221VH262014IC, H41212YY), VH262086QK (01008406821216511120052921VH262086QK, H41212YY), VH261683Q7 (01008406821216511120052921VH261683Q7, H41212YY), VH262773P1 (01008406821216511120070621VH262773P1, H41212YY), VH265406KA (01008406821216511121051821VH265406KA, H41212YY), VH263551YR (01008406821216511120101321VH263551YR, H41212YY), VH2630353P (01008406821216511120101321VH2630353P, H41212YY), VH263549DB (01008406821216511120101321VH263549DB, H41212YY), VH1632534K (01008406821216511118100021VH1632534K, H41212YY), VH160006DB (01008406821216511116080021VH160006DB, H41212RK), VH160022AZ (01008406821216511116080021VH160022AZ, H41212RK), VH264900CN (01008406821216511121030921VH264900CN, H41212YY), VH264904KF (01008406821216511121030921VH264904KF, H41212YY), VH165707BB (01008406821216511119120021VH165707BB, H41212YY)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0520-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0518-2022	Class II	Terminated	Voluntary: Firm initiated	2022-02-02	2022-01-24
Z-0519-2022	Class II	Terminated	Voluntary: Firm initiated	2022-02-02	2022-01-24
Z-0520-2022	Class II	Terminated	Voluntary: Firm initiated	2022-02-02	2022-01-24
Z-0521-2022	Class II	Terminated	Voluntary: Firm initiated	2022-02-02	2022-01-24
Z-0522-2022	Class II	Terminated	Voluntary: Firm initiated	2022-02-02	2022-01-24
Z-0523-2022	Class II	Terminated	Voluntary: Firm initiated	2022-02-02	2022-01-24
Z-0524-2022	Class II	Terminated	Voluntary: Firm initiated	2022-02-02	2022-01-24

Product code IYO

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)