Philips Respironics V60 Ventilator Recall for Navigation Ring Defects
Respironics is recalling three V60 ventilators because the navigation ring may malfunction 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 involves a critical medical device (ventilator) with a defect that can cause erratic parameter changes, posing a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Respironics California, LLC is recalling three Philips Respironics V60 Ventilators (Part Number R1053618) due to potential issues with the navigation ring interface and liquid ingress. The recall covers specific serial numbers: 100039155, 100054624, and 100054738.
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 reliability during use.
The affected units were distributed worldwide, including the United States (nationwide, Guam, and Puerto Rico) and numerous international locations. Users of these specific ventilators should contact Respironics for further instructions on how to address the navigation ring and liquid ingress issues.
The recalled product
- Product
- 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.
- Manufacturer
- Respironics California, LLC
- Category
- Medical Device — Ventilators
- Affected units
- 3
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 (3)
- Model: V60 Part Number: R1053618 V60 Ventilator
- Japan Opt: CFLEX
- AVAPS Serial Numbers: 100039155 100054624 100054738
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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