Philips Respironics V60 Plus Ventilator Recalled for Navigation Ring Issues
Respironics is recalling V60 Plus ventilators because the navigation ring may fail or cause erratic parameter changes.
The agency’s classification
FDA (Devices): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a life-support device where erratic parameter changes pose a risk of harm, though no specific injuries or illnesses are reported in the source text.
Plain-English summary
Respironics California, LLC is recalling the Philips Respironics V60 Plus Ventilator (Part Number 1138747) due to potential issues with the navigation ring interface and liquid ingress. The recall covers 682 systems, with an amendment on July 29, 2021, expanding the scope to 15,185 U.S. systems for faceplate replacement.
The identified issues include the navigation ring becoming inoperative or operating intermittently, and the ring causing ventilator parameter values to change erratically during setting entries and adjustments. These defects could compromise the device's ability to deliver consistent ventilation settings.
The affected units were distributed worldwide, including the United States (nationwide, Guam, and Puerto Rico) and numerous international locations. Consumers and healthcare facilities should check their device serial numbers against the list provided by the manufacturer and contact Respironics for instructions on repair or replacement.
The recalled product
- Product
- 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.
- Manufacturer
- Respironics California, LLC
- Category
- Medical Device — Ventilator
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Model: V60 Plus Part Number: 1138747 V60 Plus Ventilator
Distribution
Part of a larger recall action
This product is one of 16 recalled by Respironics California, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 16 products in this recall →Related recalls
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