GE Healthcare Recalls CARESCAPE R860 Ventilators Due to Oxygen Sensor Issue
GE Healthcare is recalling 2,277 CARESCAPE R860 ventilators because a potential oxygen sensor issue may cause inaccurate FiO2 readings.
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 with a potential for inaccurate delivery of a critical life-support parameter (FiO2), 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 2,277 units of the CARESCAPE R860 ventilator. The recall is due to a potential issue with the oxygen sensor that may result in an inaccurate display of the FiO2 value compared to what is actually being delivered to the patient.
The affected devices were distributed domestically in the USA and internationally in Australia, Bahrain, Bermuda, Canada, Egypt, France, Germany, Honduras, India, Iraq, Italy, Lebanon, Mexico, Panama, Peru, Russia, Saudi Arabia, Singapore, South Africa, Spain, Taiwan, and the United Arab Emirates. The recall includes specific spare parts and units identified by a long list of CBRZ identifier numbers.
Healthcare facilities should contact GE Healthcare for instructions on how to address the issue. The source text does not specify a consumer action for individual patients, as these are medical devices used in clinical settings.
The recalled product
- Product
- CARESCAPE R860 Ventilator The CARESCAPE R860 ventilator is a microprocessor based, electronically controlled, pneumatically driven ventilator that includes integrated monitoring of FiO2, airway pressure, flow, and Volume.
- Manufacturer
- GE Healthcare, LLC
- Category
- Medical Device — Ventilator
- Affected units
- 2,277
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)
- CARESCAPE R860: 1506-8600-000 Spare parts: CARESCAPE R860: 1505-3215-000
- 2071409-S
- 2071410-001 Engstrom: M1115997-S
- M1081816-S Identifier # CBRZ03152
- CBRZ03159
- CBRZ03171
- CBRZ03173
- CBRZ03174
- CBRZ03175
- CBRZ03176
- CBRZ03177
- CBRZ03180
- CBRZ03182
- CBRZ03867
- CBRZ03869
- CBRZ03870
- CBRZ03873
- CBRZ03856
- CBRZ03259
- CBRZ03261
Distribution
Distribution scope not specified by the agency.
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