GE CARESCAPE Patient Data Module Recalled for Missing Apnea Alarms
GE Medical Systems is recalling CARESCAPE Patient Data Module software because it fails to generate visual or audible alarms for impedance respiration apnea events.
What this means for you
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 involves a medical device that fails to provide critical safety alarms for apnea events. While no specific injuries or deaths are reported in the source text, the risk of harm to patients due to missed alarms is significant, fitting the criteria for a high-risk product where injury has not yet been reported.
Plain-English summary
GE Medical Systems Information Technologies, Inc. is recalling the CARESCAPE Patient Data Module (PDM) v2.6 software. This software is used with CARESCAPE Monitors B850, B650, and B450 running 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.
The recall is being issued because the device does not produce a visual or audible impedance respiration apnea alarm when an impedance respiration apnea event occurs. This failure means that healthcare providers may not be alerted to specific respiration apnea events as intended.
A total of 1,196 units are affected, including 1,176 in the United States and 20 outside the US. The devices were distributed worldwide, including in New York and Wisconsin in the US, as well as in Australia, France, and Germany. Healthcare facilities should contact GE Medical Systems for instructions on how to address the software defect.
The recalled product
- Product
- 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/be
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Model No. 2042084-001. Serial No. SA314096842GA
- SA314212130GA
- SA313430730GA
- SA313430743GA
- SA313430731GA
- SA313430735GA
- SA313430771GA
- SA313430795GA
- SA313430801GA
- SA313430806GA
- SA313430813GA
- SA313441307GA
- SA313441311GA
- SA313441399GA
- SA313441414GA
- SA313441474GA
- SA314086697GA
- SA313272250GA
- SA313378480GA
- SA313419589GA
Distribution
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