Respironics California, LLC

Complete recall history across all FDA and CPSC categories — 46 total recalls

Respironics California, LLC appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (46)

FDA medical device enforcement actions by Respironics California, LLC

Date Product Reason Class
Feb 28, 2022 Philips Respironics V60 Ventilator (All Models, including: 1053613, 1053614, ... Ventilator units have an issue impacting an internal electrical circuit withi... Class I
Feb 28, 2022 Philips Respironics V60 Plus Ventilator (All Models, including: 1138747, 1137... Ventilator units have an issue impacting an internal electrical circuit withi... Class I
Feb 28, 2022 Philips Respironics V680 Ventilator (All Models, including: P/N 1103044 (8500... Ventilator units have an issue impacting an internal electrical circuit withi... Class I
Jan 24, 2022 Philips Respironics V60 Ventilator Part Number 1053617 A limited number of ventilators were assembled with expired adhesive. If the ... Class I
Jan 24, 2022 Philips Respironics V60 Plus Ventilator Part Number 1138747 A limited number of ventilators were assembled with expired adhesive. If the ... Class I
Jun 18, 2021 Philips Respironics V60 Ventilator with Software Versions 3.00 and 3.10. T... It has been identified that ventilators equipped with High Flow Therapy (Soft... Class I
Jun 18, 2021 Philips Respironics V60 Plus Ventilator with Software Versions 3.00 and 3.10.... It has been identified that ventilators equipped with High Flow Therapy (Soft... Class I
Jan 6, 2021 PHILIPS BATTERY, V60 14.4V, 11.0 Ah, 163 Wh, REF 1076374(1058272), LOT M94663... Due to unqualified "design verification" batteries being shipped to customers. Class II
Nov 2, 2020 Philips Respironics V60 Ventilator Part Number 1053617 - Product Usage: inten... Potential issues with ventilator navigation ring interface and liquid ingress... Class II
Nov 2, 2020 Philips Respironics V60 Ventilator Part Number 1053616 - Product Usage: inten... Potential issues with ventilator navigation ring interface and liquid ingress... Class II
Nov 2, 2020 Philips Respironics V60 Plus Ventilator Part Number 1137276 - Product Usage: ... Potential issues with ventilator navigation ring interface and liquid ingress... Class II
Nov 2, 2020 Philips Respironics V60 Ventilator Part Number DU1053617 - Product Usage: int... Potential issues with ventilator navigation ring interface and liquid ingress... Class II
Nov 2, 2020 Philips Respironics V60 Ventilator Part Number 1076709 - Product Usage: inten... Potential issues with ventilator navigation ring interface and liquid ingress... Class II
Nov 2, 2020 Philips Respironics V60 Ventilator Part Number 1076716 - Product Usage: inten... Potential issues with ventilator navigation ring interface and liquid ingress... Class II
Nov 2, 2020 Philips Respironics V60 Ventilator Part Number 1053614 - Product Usage: inten... Potential issues with ventilator navigation ring interface and liquid ingress... Class II
Nov 2, 2020 Philips Respironics V60 Plus Ventilator Part Number 1138747 - Product Usage: ... Potential issues with ventilator navigation ring interface and liquid ingress... Class II
Nov 2, 2020 Philips Respironics V60 Ventilator Part Number 1053613 - Product Usage: inten... Potential issues with ventilator navigation ring interface and liquid ingress... Class II
Nov 2, 2020 Philips Respironics V680 Ventilator Part Number 850011 - Product Usage: inten... Potential issues with ventilator navigation ring interface and liquid ingress... Class II
Nov 2, 2020 Philips Respironics V60 Ventilator Part Number R1053618 - Product Usage: inte... Potential issues with ventilator navigation ring interface and liquid ingress... Class II
Nov 2, 2020 Philips Respironics V60 Ventilator Part Number 1076717 - Product Usage: inten... Potential issues with ventilator navigation ring interface and liquid ingress... Class II
Nov 2, 2020 Philips Respironics V60 Ventilator Part Number 1137292 - Product Usage: inten... Potential issues with ventilator navigation ring interface and liquid ingress... Class II
Nov 2, 2020 Philips Respironics V60 Ventilator Part Number 1053615 - Product Usage: inten... Potential issues with ventilator navigation ring interface and liquid ingress... Class II
Nov 2, 2020 Philips Respironics V60 Ventilator Part Number 1053618 - Product Usage: inten... Potential issues with ventilator navigation ring interface and liquid ingress... Class II
Nov 2, 2020 Philips Respironics V60 Ventilator Part Number R1076709 - Product Usage: inte... Potential issues with ventilator navigation ring interface and liquid ingress... Class II
Oct 30, 2020 Philips Respironics V60 Ventilator Part Number 1076717 - Product Usage: inten... Ventilator may experience potential issues with the backup battery failures: ... Class II
Oct 30, 2020 Philips Respironics V60 Ventilator Part Number 1076709 - Product Usage: inten... Ventilator may experience potential issues with the backup battery failures: ... Class II
Oct 30, 2020 Philips Respironics V60 Ventilator Part Number 1053616 - Product Usage: inten... Ventilator may experience potential issues with the backup battery failures: ... Class II
Oct 30, 2020 Philips Respironics V60 Ventilator Part Number U1053617 - Product Usage: inte... Ventilator may experience potential issues with the backup battery failures: ... Class II
Oct 30, 2020 Philips Respironics V60 Plus Ventilator Part Number 1138747 - Product Usage: ... Ventilator may experience potential issues with the backup battery failures: ... Class II
Oct 30, 2020 Philips Respironics V60 Ventilator Part Number R1076709 - Product Usage: inte... Ventilator may experience potential issues with the backup battery failures: ... Class II
Oct 30, 2020 Philips Respironics V60 Ventilator Part Number 1053617 - Product Usage: inten... Ventilator may experience potential issues with the backup battery failures: ... Class II
Oct 30, 2020 Philips Respironics V60 Ventilator Part Number 1053614 - Product Usage: inten... Ventilator may experience potential issues with the backup battery failures: ... Class II
Oct 30, 2020 Philips Respironics V60 Ventilator Part Number 1076716 - Product Usage: inten... Ventilator may experience potential issues with the backup battery failures: ... Class II
Oct 30, 2020 Philips Respironics V680 Ventilator Part Number 850011 - Product Usage: inten... Ventilator may experience potential issues with the backup battery failures: ... Class II
Oct 30, 2020 Philips Respironics V60 Ventilator Part Number 1137292 - Product Usage: inten... Ventilator may experience potential issues with the backup battery failures: ... Class II
Oct 30, 2020 Philips Respironics V60 Ventilator Part Number R1053618 - Product Usage: inte... Ventilator may experience potential issues with the backup battery failures: ... Class II
Oct 30, 2020 Philips Respironics V60 Ventilator Part Number DU1053617 - Product Usage: int... Ventilator may experience potential issues with the backup battery failures: ... Class II
Oct 30, 2020 Philips Respironics V60 Plus Ventilator Part Number 1137276 - Product Usage: ... Ventilator may experience potential issues with the backup battery failures: ... Class II
Oct 30, 2020 Philips Respironics V60 Ventilator Part Number 1053618 - Product Usage: inten... Ventilator may experience potential issues with the backup battery failures: ... Class II
Oct 30, 2020 Philips Respironics V60 Ventilator Part Number 1053613 - Product Usage: inten... Ventilator may experience potential issues with the backup battery failures: ... Class II
Oct 30, 2020 Philips Respironics V60 Ventilator Part Number 1053615 - Product Usage: inten... Ventilator may experience potential issues with the backup battery failures: ... Class II
Mar 5, 2020 Philips V60 Ventilators with Power Management PCBA part number 1055906 Solder connection failure on Power Management printed circuit board assembly ... Class II
Sep 11, 2019 Respironics V680 Ventilator, Service # 850011, (OUS Only) Ventilator touchscreen may become frozen and fail to respond to touch command... Class II
Sep 11, 2019 Respironics RP-UI Assy, V60 Ventilators User Interface RP-Kits, REF/P/N: 45... Ventilator touchscreen may become frozen and fail to respond to touch command... Class II
Sep 11, 2019 Respironics RP-Touch Screen, V60/V680 Ventilator Serviced with Touchscreen RP... Ventilator touchscreen may become frozen and fail to respond to touch command... Class II
Sep 11, 2019 Respironics V60 Ventilator, Service # 850008, REF: 1053613, 1053614, 1053617,... Ventilator touchscreen may become frozen and fail to respond to touch command... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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