Philips Respironics V60 Ventilator Recalled for Navigation Ring and Liquid Ingress Issues
Respironics is recalling V60 Ventilators because the navigation ring may malfunction or cause erratic parameter changes, and liquid may enter the device.
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 medical device that could lead to incorrect ventilation settings or device failure, posing a risk of harm to patients, although no specific injuries or illnesses are reported in the source text.
Plain-English summary
Respironics California, LLC is recalling the Philips Respironics V60 Ventilator (Part Number 1053616) due to potential issues with the navigation ring interface and liquid ingress. The recall affects 330 systems, with an amendment on July 29, 2021, expanding the scope to 44,841 U.S. systems for faceplate replacement.
The identified hazards include the navigation ring becoming inoperative or operating intermittently, and the navigation ring causing ventilator parameter values to change erratically during setting entries and adjustments. Additionally, there is a risk of liquid ingress into the device.
The affected units were distributed worldwide, including the United States (nationwide, Guam, and Puerto Rico) and numerous international locations. Consumers and healthcare providers should check their device serial numbers against the list provided by the manufacturer and contact Respironics for instructions on repairs or replacements.
The recalled product
- Product
- Philips Respironics V60 Ventilator Part Number 1053616 - 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 Part Number: 1053616 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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