GE Healthcare Carescape Patient Data Module Recall for Latch Failure
GE Healthcare is recalling Carescape Patient Data Modules due to a potential safety issue involving the intermittent failure of the spring-loaded mounting latch.
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. The hazard involves a mechanical failure of a mounting latch on a medical device used for patient monitoring, which poses a risk of harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
GE Healthcare, LLC is recalling the Carescape Patient Data Module (PDM). The PDM is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric, and neonatal patients during non-transport/bedside and transport patient care episodes.
The recall is being issued because GE Healthcare became aware of a potential safety issue due to the intermittent failure of the spring-loaded mounting latch. This issue affects PDMs produced from April 2007 through December 2012.
A total of 43,033 units are affected, with 25,681 units in the USA and 17,352 units outside the USA. The devices were distributed nationwide in the US and internationally to numerous countries. Healthcare facilities should contact GE Healthcare for instructions on how to address the defect.
The recalled product
- Product
- GE Healthcare Carescape Patient Data Module The Patient Data Module (PDM) is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal patients during non-transport/bedside and transport patient care episodes.
- Manufacturer
- GE Healthcare, LLC
Distribution
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