Reported Feb 19, 2020 · Ongoing
Respironics RP-Touch Screen, V60/V680 Ventilator Serviced with Touchscreen RP Kit 453561511951 containing a touchscreen…
Respironics California, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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: Respironics California, LLC · 2271 Cosmos Ct · Carlsbad, CA · 92011-1517
Is this the product you have?
- Respironics RP-Touch Screen, V60/V680 Ventilator Serviced with Touchscreen RP Kit 453561511951 containing a touchscreen labeled as raw part number 1132318 Revision C
- Lot codes and dates
- Touchscreen Serial Number
41088-1808-0001 to 017941213-1809-0001 to 020041305-1811-0001 to 029541379-1812-0001 to 025041379-1812-0251 to 032841540-1813-0001 to 019541633-1814-0001 to 027541633-1814-0276 to 028541724-1815-0001 to 014041724-1815-0141 to 018341838-1816-0001 to 010741838-1816-0108 to 016541930-1817-0001 to 009242059-1818-0001 to 015042059-1818-0151 to 018342161-1819-0001 to 011742161-1819-0118 to 013742232-1820-0001 to 013042232-1820-0131 to 014642334-1822-0001 to 013442334-1822-0135 to 014142471-1823-0001 to 014342471-1823-0144 to 017542805-1828-0001 to 0138
- Touchscreen Serial Number
- Amount recalled
- 800
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was recalled
Ventilator touchscreen may become frozen and fail to respond to touch commands. If a patient requires a change in therapy, there is no warning associated with an unresponsive touchcreen, and therefore the clinician would have no prior indication of a touchscreen failure and would be unable to change ventilator settings. The ventilator will continue to function at the predetermined and accepted settings required to support the patient. A delay in therapy adjustments may result in hypercarbia and/or hypoxemia.
This product could cause temporary or reversible health problems — stop using it.
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