High FDA (Devices)·Z-2171-2024·Announced 2024-07-03

GE CARESCAPE Monitors May Fail to Power On After Battery Replacement

GE Healthcare recalls CARESCAPE B650 patient monitors that may fail to power on after mains power loss following CPU timekeeper battery replacement, 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: This is a Class II recall involving medical monitors critical to patient care. No illnesses, injuries, or deaths have been reported. The hazard represents a risk-of-harm scenario where patient monitoring equipment could become inoperable, fitting the criterion for 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

GE Healthcare has issued a recall of CARESCAPE B650 patient monitors and related models (CARESCAPE Canvas 1000, Canvas Smart Display, and certain CARESCAPE B850 models) due to a potential risk of loss of monitoring. The hazard occurs if a mains power loss happens during active patient monitoring following replacement of the CPU timekeeper battery.

If mains power is lost following battery replacement, the affected monitors or displays may not turn on after power is restored. This malfunction could result in a delay in recognizing changes in patient condition until a replacement monitor is connected, potentially affecting clinical response time and patient care.

Approximately 54,800 units are affected worldwide. Specific model numbers and serial numbers are listed in the recall details. GE Healthcare recommends that healthcare facilities verify whether their CARESCAPE devices are affected and contact the manufacturer for guidance on safe battery replacement procedures or device replacement options.

The recalled product

Product: CARESCAPE B650: Model Numbers: a) MBB313, Model Numbers: 1) 2095801-001, 2) 2095801-001-01018416, 3) 2095801-001-01023150, 4) 2095801-001-01023151, 5) 2095801-001-01023152, 6) 2095801-001-01032962, 7) 2095801-001-01033915, 8) 2095801-001-01034302, 9) 2095801-001-0103
Manufacturer: GE Healthcare Finland Oy
Category: Medical Device — Patient Monitors
Hazard: monitoring-loss
device-failure
power-loss-risk
Affected units: 54,800

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)

GTIN 00840682143806: a) MBB313: 1) 2095801-001
Serial Numbers: STF21330010HA
STF21330023HA
STF21400190HA
SNS20303110SA
SNS20363001SA
SNS20392015SA
SS620481053HA
2) 2095801-001-01018416
Serial Numbers: STF22200047HA
STF22200048HA
STF22200061HA
STF22200062HA
STF22200065HA
STF22200066HA
STF22200067HA
STF22200068HA
STF22200069HA
STF22200070HA
STF22200071HA

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 5 recalled by GE Healthcare Finland Oy under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

Same manufacturer · GE Healthcare Finland Oy

See all →

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Same hazard · monitoring loss