The Recall Desk
ModerateFDA (Devices)·Z-0518-2022·Announced 2022-02-02

GE Vscan Extend ultrasound console fails to power on when battery is depleted

GE Healthcare is recalling the Vscan Extend ultrasound console due to battery depletion that prevents powering on. The problem occurs when the battery depletes if the device is not turned off before battery removal or is connected to a computer without AC power.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II medical device recall with no reported injuries or incidents. The issue is operational—the device fails to power on when the battery is depleted—rather than a direct safety hazard. Battery depletion results from user error in device handling.

Plain-English summary

GE Healthcare is recalling the Vscan Extend ultrasound console, a portable diagnostic imaging device. The recall affects 12,526 units distributed domestically across the United States and internationally to numerous countries and territories.

The device will not power on if the battery becomes depleted. According to the manufacturer, battery depletion occurs when the device is not turned off before the battery is removed or when the device is connected to a computer without AC power.

The recalled product

Product
GE Vscan Extend, being sold as "Vscan Extend Console"
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Ultrasound
Hazard
  • power-failure
  • battery-depletion

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Information reads "Serial Number (UDI
  • Model Number)". VH1622261Y (01008406821216511118042621VH1622261Y
  • 5693455)
  • VH161664XA (01008406821216511118031921VH161664XA
  • VH2627194S (01008406821216511120071321VH2627194S
  • VH160129E8 (01008406821216511117021721VH160129E8
  • VH160834YQ (01008406821216511117110021VH160834YQ
  • VH1642124F (01008406821216511119040921VH1642124F
  • VH150152W7 (01008406821216511116080021VH150152W7
  • VH160113JQ (01008406821216511117020321VH160113JQ
  • VH161979EY (01008406821216511118030021VH161979EY
  • VH162446PC (01008406821216511118061221VH162446PC
  • VH161984GS (01008406821216511118030021VH161984GS
  • VH161970GQ (01008406821216511118030021VH161970G
  • VH1619899S (01008406821216511118030021VH1619899S
  • VH160237FQ (01008406821216511117030021VH160237FQ
  • VH1600005U (5693455)
  • VH160007CX (5693455)
  • VH160009UF (5693455)
  • VH150153FK (5693455)

Distribution

Distributed in 50 states:

  • AK
  • AL
  • AR
  • AZ
  • CA
  • CO
  • CT
  • DC
  • 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
  • PR
  • RI
  • SC
  • SD
  • TN
  • TX
  • UT
  • VA
  • WA
  • WI
  • WV
  • WY

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