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.
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 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
Distribution
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