Agency classClass IIOur severity:High FDA (Devices)·Z-0587-2019·Announced 2018-12-19

GE Healthcare Recalls B105/125 Patient Monitors Due to Network Overload Risk

GE Healthcare is recalling 5,516 B105/125 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 medical device used for patient monitoring where a malfunction (restarting) poses a risk of harm by interrupting care, but no injuries or illnesses have been reported, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

GE Healthcare, LLC is recalling 5,516 B105/125 Patient Monitors. These devices are portable multiparameter units used to monitor and record physiological parameters and generate alarms for adult, pediatric, and neonatal patients in hospital environments and during intra-hospital transport. The recall covers all monitors distributed worldwide, including the United States (nationwide) and Puerto Rico, as well as numerous countries across Africa, Asia, Europe, the Middle East, North America, and South America.

The recall was initiated because the patient monitors may restart due to network overload caused by network configuration. This issue could potentially interrupt the monitoring of patients' physiological parameters. The source text does not report any specific injuries, illnesses, or deaths associated with this defect.

Healthcare facilities and consumers who possess these devices should contact GE Healthcare for instructions on how to resolve the issue. The recall number is Z-0587-2019.

The recalled product

Product: B105/125 Patient Monitor. 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 during intra-hospital…
Manufacturer: GE Healthcare, LLC
Category: Medical Device — Patient Monitor
Hazard: device-malfunction
monitoring-interruption
Affected units: 5,516

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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