Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
GE Healthcare Carescape Patient Data Module Recalled by GE Healthcare, LLC Due to GE Healthcare has recently become aware of a...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact GE Healthcare, LLC directly.
Affected Products
GE Healthcare Carescape Patient Data Module
Quantity: 68,452 (39,505 units US, 24,711 units OUS, 4,236 units unidentified/unknown)
Why Was This Recalled?
GE Healthcare has recently become aware of a potential safety issue to the ECG calculations following a disconnect/reconnect cycle with the Patient Data Module, when used with the Carescape Bx50 monitors. If the PDM is quickly disconnected and reconnected (a less than 10 second cycle) from a Carescape Bx50 monitor following a Patient Discharge or during active monitoring, the ECG waveform an
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About GE Healthcare, LLC
GE Healthcare, LLC has 474 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report