Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
CARESCAPE Patient Data Module (PDM) v2.6 software used with CARESCAPE Recalled by GE Medical Systems Information Technologies, Inc. Due to Device does not produce a visual or audible...
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 Medical Systems Information Technologies, Inc. directly.
Affected Products
CARESCAPE Patient Data Module (PDM) v2.6 software used with CARESCAPE Monitors B850, B650, and B450 v2.0.7 or earlier software 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. Physiological parameter data acquired by the PDM includes EGG, invasive blood pressure, non-invasive blood pressure, pulse oximetry, temperature, cardiac output and respiration. This device acquires, processes and stores information for all aforementioned parameters and transmits this information to a transport or bedside central processing unit for viewing and alarm surveillance purposes.
Quantity: 1,196 (1,176 US; 20 OUS)
Why Was This Recalled?
Device does not produce a visual or audible impedance respiration APN alarm when an impedance respiration apnea event occurs.
Where Was This Sold?
This product was distributed to 2 states: NY, WI
About GE Medical Systems Information Technologies, Inc.
GE Medical Systems Information Technologies, Inc. has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report