GE Healthcare: CARESCAPE R860 Ventilator Oxygen Sensor May Display Incorrect FiO2 Value
GE Healthcare recalls CARESCAPE R860 ventilators with potential oxygen sensor issue causing inaccurate FiO2 display. Affected units have specific identifiers; check your device's serial number. No immediate action needed but monitor for incorrect oxygen readings.
Lower-risk recall
The oxygen sensor for certain CARESCAPE R860 devices has a potential issue that may result in an inaccurate display of FiO2 value from what is being delivered.
Contact the company
What happened, in plain English
GE Healthcare is recalling certain CARESCAPE R860 ventilators due to a potential issue with the oxygen sensor that may cause incorrect display of the FiO2 (oxygen concentration) value. This could lead to improper oxygen delivery to patients if the display is inaccurate. The recall does not require immediate action but users should monitor the display and ensure accurate oxygen levels. Read more at govinfonow.com/recall/64727-ge-healthcare-carescape-r860-ventilator-oxygen-sensor-may-display-incorrect.
Source Summary by GovInfoNow · govinfonow.com/recall/64727-ge-healthcare-carescape-r860-ventilator-oxygen-sensor-may-display-incorrect · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2883-2020
Cite this page
“GE Healthcare: CARESCAPE R860 Ventilator Oxygen Sensor May Display Incorrect FiO2 Value.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64727-ge-healthcare-carescape-r860-ventilator-oxygen-sensor-may-display-incorrect. Based on FDA recall #Z-2883-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2883-2020%22&limit=1).
Why it’s dangerous
The oxygen sensor in certain CARESCAPE R860 ventilators may provide inaccurate readings of the FiO2 (fraction of inspired oxygen) value. This could lead to patients receiving incorrect oxygen levels if the display is not trusted. However, the ventilator continues to deliver oxygen normally, so the risk of serious injury is low.
Who’s affected
Healthcare facilities and patients using the CARESCAPE R860 ventilator. The risk is low as the issue only affects the display of oxygen concentration, not the actual delivery of oxygen.
How to tell if you have this one
Check if your CARESCAPE R860 ventilator has a serial number starting with CBRZ followed by numbers (e.g., CBRZ03152, CBRZ03159). The full list of affected units is provided in the recall notice.
- Brand
GE Healthcare- Category
Medical device
What to do — step by step
Check Your Device
Look for a serial number starting with CBRZ followed by numbers on your CARESCAPE R860 ventilator.
How this recall unfolded
Recall timeline
FDA terminated this recall 4.2 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2883-2020 (July 14, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2883-2020 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.