RecallRadar

FDA Device recall Z-0906-2021

Philips Respironics V60 Ventilator Part Number 1053617 - Product Usage: intended to be used only with various combinations of Respironics-r…

On 2021-02-03 the FDA classified a Class II recall of Philips Respironics V60 Ventilator Part Number 1053617 - Product Usage: intended to be used only with various combinations of Respironics-r… by Respironics California, citing 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….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0906-2021
ClassificationClass II
Statusongoing
Initiated2020-11-02
Published2021-02-03
Last updated2026-09-13 11:56 UTC
CompanyRespironics California
DistributionUS

Product

Philips Respironics V60 Ventilator Part Number 1053617 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.

Reason

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.

Identifiers

code_info
Model: V60 Part Number: 1053617 V60 Ventilator, English Opt: None Serial Numbers: 201000151 100109977 100090432 100091…Model: V60 Part Number: 1053617 V60 Ventilator, English Opt: None Serial Numbers: 201000151 100109977 100090432 100091177 100091771 100092004 100092037 100113859 100008140 100009121 100066005 100067771 100068862 100068864 100068866 100229881 100229933 100229936 100244028 100244036 100244037 100342231 201013345 201030470 201030473 201030478 MX0000810 MX0000813 MX0000825 MX0000828 100002909 100002910 100002912 100002915 100002998 100002999 100003000 100003002 100003004 100003006 100003019 100003040 100003041 100003042 100003043 100003044 100003045 100003047 100003048 100003049 100003050 100003051 100003053 100003080 100003082 100003083 100003084 100003085 100003086 100003087 100003088 100003089 100003090 100003091 100003092 100003148 100003149 100003658 100003659 100003661 100003662 100003663 100003664 100003665 100003666 100003667 100003668 100003669 100003670 100003671 100003672 100003673 100003680 100003681 100003682 100003683 100003684 100003686 100003687 100003688 100003690 1000036

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0906-2021%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.