Agency classClass IIOur severity:High FDA (Devices)·Z-0586-2019·Announced 2018-12-19

GE Healthcare Recalls B40i Patient Monitors Due to Network Restart Risk

GE Healthcare is recalling 6,864 B40i patient monitors worldwide because network configuration issues may cause the devices to restart unexpectedly.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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: The recall involves a high-risk medical device where unexpected restarts could compromise patient monitoring, but the source text does not report any specific injuries or illnesses, fitting the 'risk-of-harm products where injury has not yet been reported' criterion.

Plain-English summary

GE Healthcare, LLC is recalling 6,864 B40i Patient Monitors and B40i Patient Monitor V3 units. These portable multiparameter devices are used in hospital environments and during intra-hospital transport to monitor and record physiological parameters for adult, pediatric, and neonatal patients.

The recall is due to a risk that the patient monitors may restart unexpectedly. This issue is caused by network overload resulting from specific network configurations. The devices are distributed worldwide, including the United States (nationwide) and Puerto Rico, as well as numerous other countries.

Healthcare facilities should contact GE Healthcare for instructions on how to address the network configuration issue to prevent unexpected device restarts.

The recalled product

Product: B40i Patient Monitor and B40i Patient Monitor V3 The device is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and…
Manufacturer: GE Healthcare, LLC
Category: Medical Device — Patient Monitor
Hazard: unexpected-restart
network-overload
Affected units: 6,864

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 (1)

All monitors

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 5 recalled by GE Healthcare, LLC 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, LLC

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