Agency classClass IIOur severity:High FDA (Devices)·Z-0584-2019·Announced 2018-12-19

GE Healthcare Recalls PROCARE B40 Patient Monitors Due to Network Overload Risk

GE Healthcare is recalling 33,065 PROCARE B40 patient monitors 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 medical device that may restart unexpectedly, posing a risk of harm to patients due to loss of monitoring, but no specific injuries or illnesses have been reported in the source text.

Plain-English summary

GE Healthcare, LLC is recalling 33,065 PROCARE B40 Patient Monitors, including versions V1, V2, V2.1, and V3. These portable multiparameter units 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 being conducted because the patient monitors may restart due to network overload caused by network configuration. This issue affects all monitors in the affected versions.

The affected devices were distributed worldwide, including the United States (nationwide) and Puerto Rico, as well as numerous international locations. Healthcare facilities should contact GE Healthcare for further instructions on how to manage the recall and ensure patient safety.

The recalled product

Product: PROCARE B40 Patient Monitor, V1; and B40 Patient Monitor, V2, V2.1, and V3. The PROCARE Monitor B40 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…
Manufacturer: GE Healthcare, LLC
Category: Medical Device — Patient Monitor
Hazard: device-restart
loss-of-monitoring
Affected units: 33,065

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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