Philips Respironics V680 Ventilator Recalled for Navigation Ring Defects
Respironics is recalling 3,453 V680 ventilators worldwide because the navigation ring may fail 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 is classified as FDA Class II. The hazard involves a critical medical device (ventilator) where erratic parameter changes or inoperative controls pose a risk of harm to patients, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Respironics California, LLC is recalling 3,453 Philips Respironics V680 Ventilators (Part Number 850011) 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 markets.
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. These issues could affect the reliability of the device's controls.
Healthcare facilities and users should check their V680 Ventilator serial numbers against the list provided in the official recall notice. Affected units should be removed from service and replaced or repaired according to the instructions provided by Respironics.
The recalled product
- Product
- Philips Respironics V680 Ventilator Part Number 850011 - 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
- 3,453
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: V680 Part Number: 850011 V680 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.
See all 16 products in this recall →Related recalls
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