Philips Respironics V60 Ventilator Recalled for Navigation Ring Defects
Respironics is recalling 9,856 V60 Ventilators worldwide due to navigation ring issues that may cause erratic parameter changes or inoperability.
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 involves a critical medical device (ventilator) where erratic parameter changes pose a significant risk of harm to patients, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Respironics California, LLC is recalling 9,856 Philips Respironics V60 Ventilators (Part Number 1053614) due to potential issues with the navigation ring interface and liquid ingress. The recall covers units distributed worldwide, including the United States, Guam, Puerto Rico, and numerous international locations.
The identified defects may cause the navigation ring to become inoperative or operate intermittently. Additionally, the navigation ring may cause ventilator parameter values to change erratically during setting entries and adjustments. The source text does not report any illnesses, injuries, or deaths associated with this recall.
Consumers and healthcare providers should check their device serial numbers against the list provided in the official recall notice. If a device is affected, users should contact Respironics for instructions on repair or replacement. The recall was amended on July 29, 2021, to include 5 U.S. systems for faceplate replacement.
The recalled product
- Product
- 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.
- 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 (2)
- Model: V60 Part Number: 1053614 V60 Ventilator
- Intl Opt: CFLEX
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.
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