Philips Respironics V60 Ventilator Recalled for Navigation Ring and Liquid Ingress Issues
Respironics is recalling 934 V60 Ventilators worldwide due to potential navigation ring malfunctions and liquid ingress risks.
What this means for you
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 critical medical device (ventilator) where erratic parameter changes or inoperability pose a risk of harm, even though specific injuries are not reported in the source text.
Plain-English summary
Respironics California, LLC is recalling 934 units of the Philips Respironics V60 Ventilator (Part Number 1053615). The recall covers units distributed worldwide, including the United States (nationwide, Guam, and Puerto Rico) and numerous international locations. The affected devices are intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
The recall is issued due to potential issues with the ventilator's navigation ring interface and liquid ingress. Specifically, the 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.
Healthcare facilities and consumers should identify affected units by checking the serial numbers listed in the official recall notice. Users should contact Respironics for instructions on how to address the issue.
The recalled product
- Product
- 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.
- Manufacturer
- Respironics California, LLC
- Category
- Medical Device — Ventilator
- Affected units
- 934
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 Part Number: 1053615 V60 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.
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