Home / Recalls / Respironics California, LLC / Z-0662-2022

Z-0662-2022 Class I Ongoing

Recalled by Respironics California, LLC — Carlsbad, CA

Recall Details

Product Type
Devices
Report Date
March 9, 2022
Initiation Date
January 24, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
16 systems

Product Description

Philips Respironics V60 Ventilator Part Number 1053617

Reason for Recall

A limited number of ventilators were assembled with expired adhesive. If the adhesive fails, a bracket may become loose and potentially damage the capacitors, which could cause the ventilator to stop providing ventilation to the patient. This failure may either activate both visual and audible alarms, or it may not sound or display an alarm (a silent shutdown).

Distribution Pattern

U.S.: AR, CA, FL, GA, IN, LA, MD, MO, NY, PA, SC, TN and TX. O.U.S. N/A

Code Information

The Component of the Ventilators that is impacted is: N 1034132 BRACKET, CAPACITOR,MOTOR DRIVER PCB Model V60 Part Number: 1053617 Serial Numbers/UDI Code: MX0016593 / (01)00884838020054(21)MX0016593 MX0016797 / (01)00884838020054(21)MX0016797 MX0016824 / (01)00884838020054(21)MX0016824 MX0016827 / (01)00884838020054(21)MX0016827 MX0016830 / (01)00884838020054(21)MX0016830 MX0016839 / (01)00884838020054(21)MX0016839 MX0016840 / (01)00884838020054(21)MX0016840 MX0016841 / (01)00884838020054(21)MX0016841 MX0016845 (01)00884838020054(21)MX0016845 MX0016853 (01)00884838020054(21)MX0016853 MX0016867 (01)00884838020054(21)MX0016867 MX0016870 (01)00884838020054(21)MX0016870 MX0016871 (01)00884838020054(21)MX0016871 MX0016872 (01)00884838020054(21)MX0016872 MX0016875 (01)00884838020054(21)MX0016875 MX0016878 (01)00884838020054(21)MX0016878

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-0907-2022 Class I — Philips Respironics V60 Ventilator (All Models, including: 1053613, 1053614, 105 (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-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)
  • Z-0906-2021 Class II — Philips Respironics V60 Ventilator Part Number 1053617 - Product Usage: intended (November 2, 2020)