Device recall: Philips Respironics V60 Ventilator Part Number 1053613 - Product Usage: intended to be used only with various…
Class II FDA enforcement event 86697. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
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.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Respironics California, LLC started this device recall on 2 Nov 2020. The firm address in the FDA record is in Carlsbad, CA. FDA put the recall in Class II. FDA event 86697 has 16 product records. The first FDA enforcement report date is 3 Feb 2021. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Worldwide distribution - US Nationwide including Guam and Puerto Rico; Afghanistan, Albania, Algeria, Andorra, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bhutan, Bolivia, Brazil,…
Recalling firm
Respironics California, LLC, Carlsbad, CA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
16 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0902-2021 | Philips Respironics V60 Ventilator Part Number 1053613 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories. | 2,137 systems (Amended on 07/29/2021 - 12 U.S. systems for faceplate replacement) | Class II | Ongoing | 3 Feb 2021 |
| Z-0903-2021 | Philips Respironics V60 Ventilator Part Number 1053614 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories. | 9,856 systems (Amended on 07/29/2021 - 5 U.S. systems for faceplate replacement) | Class II | Ongoing | 3 Feb 2021 |
| Z-0904-2021 | Philips Respironics V60 Ventilator Part Number 1053615 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories. | 934 systems | Class II | Ongoing | 3 Feb 2021 |
| Z-0905-2021 | Philips Respironics V60 Ventilator Part Number 1053616 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories. | 330 systems (Amended on 07/29/2021 - 44,841 U.S. systems for faceplate replacement) | Class II | Ongoing | 3 Feb 2021 |
| Z-0906-2021 | 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. | 46,247 systems (Amended on 07/29/2021 - 52,164 U.S. systems for faceplate replacement) | Class II | Ongoing | 3 Feb 2021 |
| Z-0907-2021 | Philips Respironics V60 Ventilator Part Number 1053618 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories. | 534 systems | Class II | Ongoing | 3 Feb 2021 |
| Z-0908-2021 | Philips Respironics V60 Ventilator Part Number 1076709 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories. | 3,752 systems | Class II | Ongoing | 3 Feb 2021 |
| Z-0909-2021 | 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. | 3 systems | Class II | Ongoing | 3 Feb 2021 |
| Z-0910-2021 | Philips Respironics V60 Ventilator Part Number R1076709 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories. | 3213 systems | Class II | Ongoing | 3 Feb 2021 |
| Z-0911-2021 | Philips Respironics V60 Ventilator Part Number 1076716 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories. | 10,291 systems | Class II | Ongoing | 3 Feb 2021 |
| Z-0912-2021 | Philips Respironics V60 Ventilator Part Number 1076717 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories. | 216 systems | Class II | Ongoing | 3 Feb 2021 |
| Z-0913-2021 | Philips Respironics V60 Plus Ventilator Part Number 1137276 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories. | 3,841 systems | Class II | Ongoing | 3 Feb 2021 |
| Z-0914-2021 | Philips Respironics V60 Ventilator Part Number 1137292 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories. | 834 systems | Class II | Ongoing | 3 Feb 2021 |
| Z-0915-2021 | Philips Respironics V60 Plus Ventilator Part Number 1138747 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories. | 682 systems (Amended on 07/29/2021 - 15,185 U.S. systems for faceplate replacement) | Class II | Ongoing | 3 Feb 2021 |
| Z-0916-2021 | Philips Respironics V60 Ventilator Part Number DU1053617 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories. Philips Respironics V60 Ventilator Part Number U1053617 - Product Usage: intended to be used… | 481 systems (DU1053617)(Amended 07/29/2021 - 44,666 U.S. systems for faceplate replacement), and 292 systems… | Class II | Ongoing | 3 Feb 2021 |
| Z-0917-2021 | Philips Respironics V680 Ventilator Part Number 850011 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories. | 3,453 systems | Class II | Ongoing | 3 Feb 2021 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2020
- 916
- Share of these events in Class II
- 93%
- Product records in this event
- 16Median of the firm: 3
- Events of the firm on the register
- 8
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 28 Feb 2022 | Philips Respironics V60 Ventilator (All Models, including: 1053613, 1053614, 1053615, 1053616, 1053617, 1053618, 1076709 | Device | Class I | 3 |
| 24 Jan 2022 | Philips Respironics V60 Ventilator Part Number 1053617 | Device | Class I | 2 |
| 18 Jun 2021 | Philips Respironics V60 Ventilator with Software Versions 3.00 and 3.10. The Respironics V60/V60 Plus Ventilator is an a | Device | Class I | 2 |
| 6 Jan 2021 | PHILIPS BATTERY, V60 14.4V, 11.0 Ah, 163 Wh, REF 1076374(1058272), LOT M94663-P1 - Product Usage: The ventilator is inte | Device | Class II | 1 |
| 30 Oct 2020 | Philips Respironics V60 Ventilator Part Number 1053613 - Product Usage: intended to be used only with various combinatio | Device | Class II | 17 |
| 5 Mar 2020 | Philips V60 Ventilators with Power Management PCBA part number 1055906 | Device | Class II | 1 |
| 11 Sep 2019 | Respironics V60 Ventilator, Service # 850008, REF: 1053613, 1053614, 1053617, 1053614 | Device | Class II | 4 |
Official channels
- FDA enforcement report Z-0902-2021The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 86697. https://recallregister.com/fda/ii/86697/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Worldwide distribution - US Nationwide including Guam and Puerto Rico; Afghanistan, Albania, Algeria, Andorra, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bhutan, Bolivia, Brazil,…
- What quantity of product is in FDA event 86697?
- The event has 16 product records. The first record gives this quantity:
2,137 systems (Amended on 07/29/2021 - 12 U.S. systems for faceplate replacement)
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2020 have the same class?
- 93% of the 916 device events that started in 2020 are in Class II.