GE Healthcare Patient Data Module Recall for ECG Noise
GE Healthcare is recalling 2,516 Patient Data Modules due to intermittent noise on ECG and respiration waveforms that may reduce monitoring performance.
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 of a critical monitoring device (ECG/Respiration), which poses a risk of harm to patients, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
GE Healthcare, LLC is recalling 2,516 units of the Solar 8000 and Transport Pro with Patient Data Module (marketed as GE Healthcare CARESCAPE Patient Data Module). The recall involves 2,321 units in the US and 195 units outside the US. The affected devices are intended for use in professional medical facilities to monitor physiologic parameters for adult, pediatric, and neonatal patients.
The recall is due to intermittent noise on ECG and/or Respiration waveforms associated with the movement of the ECG cable connector on the DASH, PDM, and/or Tram Module. This issue may result in reduced ECG, Respiration, and arrhythmia detection performance.
The devices were distributed nationwide in the US (excluding South Dakota, Vermont, and Wyoming) and internationally to numerous countries including Canada, the United Kingdom, Germany, and Japan. Healthcare facilities should contact GE Healthcare for instructions on how to address the issue.
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 patients…
- 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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Similar recalls
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