The Recall Desk
ModerateFDA (Devices)·Z-0520-2022·Announced 2022-02-02

GE Vscan Extend Ultrasound Device Battery Power Failure Recall

GE Healthcare recalls the Vscan Extend portable ultrasound device because the battery may become depleted and prevent the device from powering on if not turned off before battery removal or when used 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 a Class II FDA recall with no reported injuries or illnesses. The hazard is device malfunction where the battery may become depleted, preventing power-on. This is primarily a functionality issue rather than a direct physical or chemical safety threat.

Plain-English summary

GE Healthcare, LLC is recalling the Vscan Extend portable ultrasound device, sold as the "Vscan Extend Dual USB". The device will not power on if its battery becomes depleted when the device is not turned off prior to battery removal or when the device is connected to a computer without AC power.

Affected devices have been distributed domestically throughout all 50 United States, the District of Columbia, and Puerto Rico. The device has also been distributed internationally to numerous countries across Europe, Asia, the Middle East, Africa, South America, and other regions. Approximately 77 units of this specific model have been identified in the recall.

Consumers who own affected devices should discontinue use and contact GE Healthcare, LLC for instructions on how to address the issue. The device should not be relied upon until the issue has been resolved by the manufacturer.

The recalled product

Product
GE Vscan Extend, being sold as "Vscan Extend Dual USB"
Manufacturer
GE Healthcare, LLC
Hazard
  • device-malfunction
  • power-failure

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 Nubmer)". VH1602482A (01008406821216511117040721VH1602482A
  • H41212RK)
  • VH160398U2 (01008406821216511117040021VH160398U2
  • VH160910MS (01008406821216511117090021VH160910MS
  • VH160692PU (01008406821216511117060021VH160692PU
  • VH16072033 (01008406821216511117060021VH16072033
  • VH164639E1 (01008406821216511119060021VH164639E1
  • H41212YY)
  • VH165023E4 (01008406821216511119090021VH165023E4
  • VH26557563 (01008406821216511121071221VH26557563
  • VH265583RM (01008406821216511121070921VH265583RM
  • VH2656017N (01008406821216511121070821VH2656017N
  • VH265638Q4 (01008406821216511121070921VH265638Q4
  • VH26564046 (01008406821216511121070921VH26564046
  • VH265645Q7 (01008406821216511121070821VH265645Q7
  • VH265647U2 (01008406821216511121070921VH265647U2
  • VH265836ZG (01008406821216511121071221VH265836ZG
  • VH265838JV (01008406821216511121071221VH265838JV
  • VH265842CE (01008406821216511121071221VH265842CE

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