High FDA (Devices)·Z-0648-2014·Announced 2014-01-15

GE Healthcare Recalls Patient Data Modules Due to Heat Buildup Risk

GE Healthcare is recalling 17,444 Patient Data Modules used with SOLAR 8000 and Transport Pro monitors. The recall addresses a potential safety issue where fluid ingress can cause heat buildup.

What this means for you

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 is classified as FDA Class II and involves a risk-of-harm product (heat buildup) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

GE Healthcare, LLC is recalling the SOLAR 8000 and Transport Pro with Patient Data Module, marketed as the GE Healthcare CARESCAPE Patient Data Module. The recall covers 17,444 units, including 11,418 units in the United States and 6,026 units outside the US. These devices were distributed nationwide in the US and internationally to numerous countries.

The recall was initiated because GE Healthcare became aware of a potential safety issue affecting Patient Data Modules produced from April 2007 through June 2010. The issue involves fluid ingress into the top cover assembly, which can result in heat buildup. The agency has classified this recall as Class II.

Healthcare facilities and users should check their device serial numbers against the list provided in the official recall notice to determine if their units are affected. No specific consumer action instructions are provided in the source text beyond the identification of the affected serial numbers.

The recalled product

Product: SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data Module)
Manufacturer: GE Healthcare, LLC
Category: Medical Device — Patient Monitoring
Hazard: heat-buildup
fluid-ingress

Distribution

Distributed nationwide across the United States.

The notice also names 44 states specifically:

Same manufacturer · GE Healthcare, LLC

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Same hazard · heat buildup