Agency classClass IIOur severity:High FDA (Devices)·Z-0927-2014·Announced 2014-02-12

GE Healthcare Recalls CARESCAPE Monitor B850 Due to Communication Loss

GE Healthcare is recalling 12,945 CARESCAPE Monitor B850 units worldwide because the F5-01 Frame may lose communication with the patient monitor.

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 a communication failure could lead to a lack of patient monitoring data, representing a risk of harm even though no specific injuries are reported in the source text.

Plain-English summary

GE Healthcare, LLC is recalling the CARESCAPE Monitor B850, a multi-parameter high acuity patient monitor used in professional healthcare facilities. The recall involves 12,945 units distributed worldwide, including 6,239 in the United States and 6,706 outside the US.

The recall is due to a potential for communication loss between the F5-01 Frame and the CARESCAPE Patient Data Module (PDM). The PDM can spontaneously lose communication with the host patient monitor when attached to the F5-01 Frame due to an issue with the PDM Ethernet communication hardware. This may result in the loss of patient parameter data.

Healthcare facilities should check their inventory for affected serial numbers and contact GE Healthcare for instructions on corrective action. The affected units are intended for use on adult, pediatric, and neonatal patients under the supervision of licensed healthcare practitioners.

The recalled product

Product: CARESCAPE Monitor B850, a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility. Product Usage: The CARESCAPE Monitor B850 is intended for use on adult, pediatric, and neonatal patients and on one patient…
Manufacturer: GE Healthcare, LLC
Category: Medical Device — Patient Monitor
Hazard: communication-loss
data-loss

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)

serial numbers: SEG09270517HX
SEG09270549HX
SEG09270551HX
SEG09270553HX
SEG09270554HX
SEG09270557HX
SEG09270559HX
SEG09270561HX
SEG09270562HX
SEG09270563HX
SEG09270564HX
SEG09270565HX
SEG09270566HX
SEG09270567HX
SEG09270568HX
SEG09270569HX
SEG09270583HX
SEG09270584HX
SEG09270585HX
SEG09270587HX

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Same manufacturer · GE Healthcare, LLC

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