medical Class II Updated 2020-02-19

Respironics California, LLC recalls Respironics RP-Touch Screen, V60/V680 Ventilator Serviced wi

Recalled Product

Respironics RP-Touch Screen, V60/V680 Ventilator Serviced with Touchscreen RP Kit 453561511951 containing a touchscreen labeled as raw part number 1132318 Revision C


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Touchscreen Serial Number: 41088-1808-0001 to 0179, 41213-1809-0001 to 0200, 41305-1811-0001 to 0295, 41379-1812-0001 to 0250, 41379-1812-0251 to 0328, 41540-1813-0001 to 0195, 41633-1814-0001 to 0275, 41633-1814-0276 to 0285, 41724-1815-0001 to 0140, 41724-1815-0141 to 0183, 41838-1816-0001 to 0107, 41838-1816-0108 to 0165, 41930-1817-0001 to 0092, 42059-1818-0001 to 0150, 42059-1818-0151 to 0183, 42161-1819-0001 to 0117, 42161-1819-0118 to 0137, 42232-1820-0001 to 0130, 42232-1820-0131 to 0146, 42334-1822-0001 to 0134, 42334-1822-0135 to 0141, 42471-1823-0001 to 0143, 42471-1823-0144 to 0175, 42805-1828-0001 to 0138
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