Agency classClass IIOur severity:High FDA (Devices)·Z-0583-2019·Announced 2018-12-19

GE Healthcare Recalls PROCARE B20 Patient Monitors Due to Network Issues

GE Healthcare is recalling 28,004 PROCARE B20 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 where a malfunction (unexpected restart) poses a risk of harm to patients, but no specific injuries or illnesses have been reported in the source text.

Plain-English summary

GE Healthcare, LLC is recalling 28,004 PROCARE B20 Patient Monitors, including versions V1 and V2. These portable multiparameter units are used in hospital environments and during intrahospital transport to monitor and record physiological parameters for adult, pediatric, and neonatal patients.

The recall was initiated because the patient monitors may restart due to network overload caused by network configuration. This issue affects devices distributed worldwide, including the United States (nationwide) and Puerto Rico, as well as numerous countries across multiple continents.

Healthcare facilities should contact GE Healthcare for instructions on how to address the network configuration issue. Consumers and patients should not use the affected monitors until the issue is resolved by the manufacturer.

The recalled product

Product: PROCARE B20 Patient Monitor, V1; and B20 Patient Monitor, V2. The PROCARE Monitor B20 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…
Manufacturer: GE Healthcare, LLC
Category: Medical Device — Patient Monitor
Hazard: device-malfunction
unexpected-restart
Affected units: 28,004

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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