Home / Recalls / Respironics California, LLC / Z-0909-2021

Z-0909-2021 Class II Ongoing

Recalled by Respironics California, LLC — Carlsbad, CA

Recall Details

Product Type
Devices
Report Date
February 3, 2021
Initiation Date
November 2, 2020
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3 systems

Product Description

Philips Respironics V60 Ventilator Part Number R1053618 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.

Reason for Recall

Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically during setting entries and adjustments.

Distribution Pattern

Worldwide distribution - US Nationwide including Guam and Puerto Rico; Afghanistan, Albania, Algeria, Andorra, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bhutan, Bolivia, Brazil, Bulgaria, Burkina Faso, Cambodia, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Ethiopia, Finland, France, French Guiana, French Polynesia, Germany, Ghana, Gibraltar, Greece, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Latvia, Lebanon, Libya, Luxembourg, Malaysia, Maldives, Mali, Malta, Mexico, Monaco, Mongolia, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Caledonia, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Fed., Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, ST. Pier Miquel, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, Venezuela, Vietnam, Wallis Futuna, and Zambia.

Code Information

Model: V60 Part Number: R1053618 V60 Ventilator, Japan Opt: CFLEX,AVAPS Serial Numbers: 100039155 100054624 100054738

Other recalls by Respironics California, LLC

  • Z-0907-2022 Class I — Philips Respironics V60 Ventilator (All Models, including: 1053613, 1053614, 105 (February 28, 2022)
  • 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-0663-2022 Class I — Philips Respironics V60 Plus Ventilator Part Number 1138747 (January 24, 2022)
  • Z-0662-2022 Class I — Philips Respironics V60 Ventilator Part Number 1053617 (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-0910-2021 Class II — Philips Respironics V60 Ventilator Part Number R1076709 - Product Usage: intende (November 2, 2020)
  • Z-0911-2021 Class II — Philips Respironics V60 Ventilator Part Number 1076716 - Product Usage: intended (November 2, 2020)