GE Healthcare Recalls CARESCAPE R860 Inspiratory Safety Guards

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 0

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.

Distribution

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