The Recall Desk
HighFDA (Devices)·Z-2172-2024·Announced 2024-07-03

CARESCAPE Patient Monitors May Not Power On After Battery Replacement

Certain GE CARESCAPE patient monitors may fail to power on after mains power loss during battery maintenance, potentially delaying recognition of patient condition changes.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall without reported illnesses, injuries, or hospitalization. The hazard—device failure to power on following battery maintenance—represents a risk-of-harm situation without reported adverse events, placing it in the 'High' severity category.

Plain-English summary

GE Healthcare has identified a potential issue with CARESCAPE B850, B650, Canvas 1000, and Canvas Smart Display patient monitors. When a mains power loss occurs during active patient monitoring following replacement of the CPU timekeeper battery, the affected monitors may not turn on when power is restored.

These devices are used in healthcare facilities to display patient vital sign information and monitor patient condition. Loss of display capability as a result of this issue could delay recognition of changes in patient condition until a replacement monitor is connected.

Affected units were distributed worldwide. Healthcare facilities using affected CARESCAPE monitors should contact GE Healthcare for guidance regarding their devices.

The recalled product

Product
CARESCAPE B850 Model Numbers: a) MBC303, Model Numbers: 1) 2078633-001, 2) 2078633-010, 3) 2078633-012, 4) 2078633-017, 5) 2078633-028, 6) 2095802-001-54069330, 7) 2095802-001-554922, 8) 2095802-001-554923, 9) 2095802-001-554924, 10) 2095802-001-554925, 11) 2095802
Manufacturer
GE Healthcare Finland Oy
Category
Medical Device — Patient Monitor
Hazard
  • monitoring-loss
  • device-shutdown
  • power-loss

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)

  • a) model MBC303: 1) 2078633-001
  • UDI/DI none
  • Serial Numbers: 2293663-1-1
  • 2) 2078633-010
  • Serial Numbers: 2284163-2-1
  • 2284112-3-1
  • 2284163-1-1
  • 2284112-4-1
  • 2262484-1-1
  • 2262484-1-2
  • 3) 2078633-012
  • Serial Numbers: 2400553-4-1
  • 2266860-3-2
  • 4) 2078633-017
  • Serial Numbers: 2261264-2-1
  • 2290421-2-1
  • 2288663-1-1
  • 2290422-2-1
  • 2312000-3-1
  • 2311672-4-1

Distribution

Distribution scope not specified by the agency.

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