Respironics RP-UI Assy, V60 Ventilators User Interface RP-Kits, REF/P/N: 453561528931, 453561528941, 453561536451, 453561536461

Reason: 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.

Code information: Serial Numbers: 100270400, 100270407, 100256220, 100270404, 100263004, 100266507, 100270402, 100263001, 100263009, 100258193, 100258197, 100258883, 100262978, 100263006, 100258196, 100256196, 100256197, 100256198, 100263003, 100266499, 100266505, 100258889, 100256192, 100258887, 100266509, 100270408, 100262976, 100258881, 100258880, 100266511, 100270406, 100258885, 100256223, 100263000, 100258884, 100258888, 100266500, 100266504, 100258886, 100256222, 100256195, 100256199, 100266502, 100266508, 100266510, 100270403, 100270490, 100257708, 100257713, 100257716, 100256831, 100256834, 100256837, 100262373, 100262556, 100262575, 100265136

Distribution pattern: US Nationwide. OUS (Foreign): Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Finland, France, Germany, Greece, Hong Kong, Iceland, India, Indonesia, Israel, Italy, Malaysia, Mexico, Netherlands, Portugal, Singapore, South Africa, Spain, Sweden, United Arab Emirates, United Kingdom, Viet Nam, Oman, Philippines, Saudi Arabia, Taiwan, Turkey, Russian Federation, Argentina, Ecuador, Poland, Guatemala, Peru, Viet Nam