GE Healthcare recalls R860 ventilator Inspiratory Safety Guards with specific part numbers due to risk of disconnecting from breathing circuit, potentially causing oxygen deprivation in patients.
The ventilator Inspiratory Safety Guard (ISG) may disconnect from the breathing circuit pathway. As a result, this could create a loss of ventilation which may lead to inadequate oxygenation for patients, increasing the possibility of hypoxia.
GE Healthcare is recalling certain R860 ventilator Inspiratory Safety Guards that may disconnect from the breathing circuit, leading to potential oxygen deprivation for patients. This recall affects medical devices used in hospitals and clinics for ventilating patients.
The Inspiratory Safety Guard (ISG) may disconnect from the breathing circuit pathway, causing a loss of ventilation. This can result in inadequate oxygenation for patients, increasing the risk of hypoxia (oxygen deprivation).
Healthcare facilities using GE Healthcare R860 ventilators with the recalled part numbers are most at risk. Patients receiving mechanical ventilation through these devices could experience oxygen deprivation if the guard disconnects.
Check for part numbers 2066713-001 (single pack) or 2083208-001 (box of ten singles) on the R860 ventilator. The affected units have specific lot numbers listed in the recall notice.
Identify the part numbers and lot numbers listed in the recall notice to determine if your device is affected.
The ventilator Inspiratory Safety Guard may disconnect from the breathing circuit, potentially causing a loss of ventilation and oxygen deprivation for patients.
Part numbers 2066713-001 (single pack) and 2083208-001 (box of ten singles) are affected.
Check for the specific part numbers and lot numbers listed in the recall notice, which include 17/00951 through 18/00130.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0463-2019 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-0463-2019 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.
