GE Healthcare Recalls Patient Data Modules Due to Signal Noise
GE Healthcare is recalling CARESCAPE Patient Data Modules because movement of the ECG connector can cause signal noise, potentially reducing the device's ability to detect arrhythmias.
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 reduced performance in arrhythmia detection, which is a risk-of-harm scenario for a medical device, but the source text does not report any specific injuries or illnesses.
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 involves 16,462 units distributed worldwide, including 8,497 in the United States and 7,307 outside the U.S.
The recall was initiated because GE Healthcare became aware of a potential safety issue where movement of the ECG connector on the DASH, PDM, and/or Tram Module can cause intermittent noise on ECG and Respiration waveforms. This signal noise may result in reduced performance for ECG, Respiration, and arrhythmia detection.
The affected devices are intended to provide uninterrupted acquisition of physiologic parameter data for adult, pediatric, and neonatal patients during bedside and transport care. 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.
The recalled product
- Product
- SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data Module) Product Usage: The Patient Data Module (PDM) is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal…
- Manufacturer
- GE Healthcare, LLC
Distribution
Part of a larger recall action
This product is one of 3 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 3 products in this recall →Related recalls
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