Philips Respironics V60 Ventilator Recall for Navigation Ring Defects
Respironics is recalling V60 ventilators because the navigation ring may fail or cause erratic parameter changes.
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 life-support device (ventilator) where erratic parameter changes could lead to patient harm, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Respironics California, LLC is recalling Philips Respironics V60 Ventilators (Part Numbers DU1053617 and U1053617) due to potential issues with the navigation ring interface and liquid ingress. The recall covers 481 systems of Part Number DU1053617 and 292 systems of Part Number U1053617, with an amended count of 44,666 U.S. systems for faceplate replacement for DU1053617 and 7,770 for U1053617.
The identified defects 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. These issues are associated with liquid ingress into the device.
The affected ventilators were distributed worldwide, including the United States (nationwide, Guam, and Puerto Rico) and numerous international countries. Consumers and healthcare facilities should check their device serial numbers against the recall list and contact Respironics for instructions on faceplate replacement or other corrective actions.
The recalled product
- Product
- Philips Respironics V60 Ventilator Part Number DU1053617 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories. Philips Respironics V60 Ventilator Part Number U105
- 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 (5)
- Model: V60 Part Number: DU1053617 V60 Ventilator
- Part Number U1053617 V60 Ventilator
- USED ENGL OPT:CFLEX
- AVAPS
- PPV
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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