GE Healthcare Carescape Patient Data Module Recalled for ECG Calculation Errors
GE Healthcare is recalling Carescape Patient Data Modules due to potential ECG calculation errors after quick disconnect/reconnect cycles with Bx50 monitors.
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 a medical device that could provide incorrect ECG data, posing a risk of harm to patients, but the source text does not report any actual injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
GE Healthcare, LLC is recalling 68,452 units of the Carescape Patient Data Module (PDM) worldwide. The recall involves 39,505 units in the United States, 24,711 units outside the U.S., and 4,236 units with unidentified distribution. The affected modules were distributed in the U.S. (excluding DE, HI, ND, SD, and WY) and in numerous countries across South America, Europe, Asia, Africa, and Oceania.
The recall is due to a potential safety issue where ECG calculations may be incorrect if the PDM is quickly disconnected and reconnected (a cycle of less than 10 seconds) from a Carescape Bx50 monitor. This specific sequence of events can occur following a patient discharge or during active monitoring. The source text does not report any illnesses, injuries, or deaths associated with this defect.
Healthcare facilities and users should identify affected units by checking the serial numbers listed in the official recall notice. Users should contact GE Healthcare for instructions on how to resolve the issue, which may involve software updates or hardware replacement, to ensure accurate ECG monitoring.
The recalled product
- Product
- GE Healthcare Carescape Patient Data Module
- Manufacturer
- GE Healthcare, LLC
Distribution
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