Reported Dec 12, 2018 · Terminated
GE HEALTHCARE CARESCAPE R860 Inspiratory Safety Guard, Part Numbers: a) 2066713-001 (single pack) b) 2083208-001 (box…
GE Healthcare, LLC
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Healthcare, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
- GE HEALTHCARE CARESCAPE R860 Inspiratory Safety Guard
- Part Numbersa) 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 0.25 kg and above. The CARESCAPE R860 ventilator is a microprocessor based, electronically controlled, pneumatically driven ventilator that includes integrated monitoring of FiO2, airway pressure, flow, and volume
- Lot codes and dates
- a) 2066713-001 Lot Numbers
17/0095117/0117417/0193717/0199417/0237217/0239318/0012618/0012718/0012818/0012918/00130
- b) 2083208-001 Lot Numbers
17/0095117/0117417/0193717/0199417/0237217/0239318/0012618/0012718/0012818/0012918/00130
- a) 2066713-001 Lot Numbers
- Amount recalled
- 1140 units (307 units in US)
Where it was sold
- Nationwide
- PR
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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