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.
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.
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.
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.
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.
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.
Look for a serial number starting with CBRZ followed by numbers on your CARESCAPE R860 ventilator.
No, the recall indicates a potential issue with the oxygen sensor display, not the actual oxygen delivery. The risk of serious injury is low.
No, the recall does not require immediate action. Users should monitor the oxygen display and ensure accurate oxygen levels.
Check your ventilator's serial number; if it starts with CBRZ followed by numbers (e.g., CBRZ03152), it is affected.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2883-2020 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-2883-2020 from GE Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
