Home / Recalls / Respironics California, LLC / Z-1154-2020

Z-1154-2020 Class II Ongoing

Recalled by Respironics California, LLC — Carlsbad, CA

Recall Details

Product Type
Devices
Report Date
February 19, 2020
Initiation Date
September 11, 2019
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
800

Product Description

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

Reason for Recall

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.

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

Code Information

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

Other recalls by Respironics California, LLC

  • Z-0909-2022 Class I — Philips Respironics V680 Ventilator (All Models, including: P/N 1103044 (850011) (February 28, 2022)
  • Z-0908-2022 Class I — Philips Respironics V60 Plus Ventilator (All Models, including: 1138747, 1137276 (February 28, 2022)
  • Z-0907-2022 Class I — Philips Respironics V60 Ventilator (All Models, including: 1053613, 1053614, 105 (February 28, 2022)
  • Z-0662-2022 Class I — Philips Respironics V60 Ventilator Part Number 1053617 (January 24, 2022)
  • Z-0663-2022 Class I — Philips Respironics V60 Plus Ventilator Part Number 1138747 (January 24, 2022)
  • Z-2074-2021 Class I — Philips Respironics V60 Plus Ventilator with Software Versions 3.00 and 3.10. (June 18, 2021)
  • Z-2073-2021 Class I — Philips Respironics V60 Ventilator with Software Versions 3.00 and 3.10. The (June 18, 2021)
  • Z-1137-2021 Class II — PHILIPS BATTERY, V60 14.4V, 11.0 Ah, 163 Wh, REF 1076374(1058272), LOT M94663-P1 (January 6, 2021)
  • Z-0903-2021 Class II — Philips Respironics V60 Ventilator Part Number 1053614 - Product Usage: intended (November 2, 2020)
  • Z-0908-2021 Class II — Philips Respironics V60 Ventilator Part Number 1076709 - Product Usage: intended (November 2, 2020)