Agency classClass IOur severity:Severe FDA (Devices)·Z-0463-2019·Announced 2018-12-12

GE Healthcare Recalls CARESCAPE R860 Inspiratory Safety Guards

GE Healthcare is recalling CARESCAPE R860 Inspiratory Safety Guards because they may disconnect from the breathing circuit, potentially causing loss of ventilation and hypoxia in patients.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class I, which mandates a severity score of at least 4 per the rubric. Additionally, the hazard involves a structural defect in a life-support device that could lead to hypoxia, a significant injury risk.

Plain-English summary

GE Healthcare, LLC is recalling the CARESCAPE R860 Inspiratory Safety Guard (part numbers 2066713-001 and 2083208-001). The recall involves 1,140 units worldwide, including 307 units in the United States. The affected lots are 17/00951, 17/01174, 17/01937, 17/01994, 17/02372, 17/02393, 18/00126, 18/00127, 18/00128, 18/00129, and 18/00130.

The recall was initiated because the Inspiratory Safety Guard may disconnect from the breathing circuit pathway. This disconnection could create a loss of ventilation, leading to inadequate oxygenation for patients and increasing the possibility of hypoxia. The CARESCAPE R860 ventilator is designed to provide mechanical ventilation or support to neonatal, pediatric, and adult patients weighing 0.25 kg and above.

The product was distributed worldwide, including the United States (nationwide including Puerto Rico) and numerous other countries. Healthcare facilities should contact GE Healthcare for instructions on how to address the issue and replace the affected components.

The recalled product

Product: GE HEALTHCARE CARESCAPE R860 Inspiratory Safety Guard, Part Numbers: a) 2066713-001 (single pack) b) 2083208-001 (box of ten singles) The CARESCAPE R860 ventilator is designed to provide mechanical ventilation or support to neonatal, pediatric, and adult patients weighing…
Manufacturer: GE Healthcare, LLC
Category: Medical Device — Ventilator Component
Hazard: hypoxia
loss-of-ventilation
mechanical-failure

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 (12)

a) 2066713-001 Lot Numbers: 17/00951
17/01174
17/01937
17/01994
17/02372
17/02393
18/00126
18/00127
18/00128
18/00129
18/00130 b) 2083208-001 Lot Numbers: 17/00951
18/00130

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Same manufacturer · GE Healthcare, LLC

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