Philips Respironics V60 Ventilator Recalled for Navigation Ring Defects
Respironics is recalling 534 V60 Ventilators worldwide due to navigation ring malfunctions 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 is classified as FDA Class II. The hazard involves a critical life-support device where erratic parameter changes pose a significant risk of harm, but the source text does not report specific injuries or fatalities, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Respironics California, LLC is recalling 534 units of the Philips Respironics V60 Ventilator (Part Number 1053618). The recall covers units distributed worldwide, including the United States, Guam, Puerto Rico, and numerous international markets.
The recall is issued because the ventilator's navigation ring may become inoperative or operate intermittently. Additionally, the navigation ring may cause ventilator parameter values to change erratically during setting entries and adjustments. The product is intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
Consumers 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 corrective actions.
The recalled product
- Product
- 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.
- Manufacturer
- Respironics California, LLC
- Category
- Medical Device — Ventilator
- Affected units
- 534
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: 1053618 V60 Ventilator
- Japan 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.
See all 16 products in this recall →Related recalls
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