GE Healthcare, LLC recalls GE HEALTHCARE CARESCAPE R860 Inspiratory Safety Guard, Part Numbers: a) 2066713-001 (single pack) b) 2083208-001 (box
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.
Use caution until it’s fixed
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.
Contact the company & request your remedy
What happened, in plain English
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. Read more at govinfonow.com/recall/69663-ge-healthcare-r860-inspiratory-safety-guard-recall-risk-of-ventilation.
Source Summary by GovInfoNow · govinfonow.com/recall/69663-ge-healthcare-r860-inspiratory-safety-guard-recall-risk-of-ventilation · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0463-2019
Cite this page
“GE Healthcare R860 Inspiratory Safety Guard Recall: Risk of Ventilation Loss.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69663-ge-healthcare-r860-inspiratory-safety-guard-recall-risk-of-ventilation. Based on FDA recall #Z-0463-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0463-2019%22&limit=1).
Why it’s dangerous
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).
Who’s affected
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.
How to tell if you have this one
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.
- Brand
GE Healthcare- Category
Medical device
What to do — step by step
Check Product Details
Identify the part numbers and lot numbers listed in the recall notice to determine if your device is affected.
Questions people ask
Why is this recall happening?
The ventilator Inspiratory Safety Guard may disconnect from the breathing circuit, potentially causing a loss of ventilation and oxygen deprivation for patients.
What part numbers are affected?
Part numbers 2066713-001 (single pack) and 2083208-001 (box of ten singles) are affected.
How can I tell if my device is recalled?
Check for the specific part numbers and lot numbers listed in the recall notice, which include 17/00951 through 18/00130.
Contact GE Healthcare
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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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-0463-2019 (October 5, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0463-2019 to see it in context.
- Plain-language summary written by qwen3:4b on August 20, 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.