Z-2025-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- July 5, 2023
- Initiation Date
- May 15, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 22 units
Product Description
Philips Respironics V60 Ventilator-Intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Model Number: R1053618 and R1076709. These are retrofitted device.
Reason for Recall
Devices were imported with Japanese Language and NIST Oxygen Gas Fittings and retrofitted, may pose a serious health risk as the gas pathway of these devices may be contaminated.
Distribution Pattern
US: CA, FL
Code Information
USI-DI: 00884838009868 Serial Numbers: Serial Number 100043954 100050078 100052760 100052848 100054619 100054626 100055277 100055557 100058549 100058566 100058837 100058995 100060228 100065373 100069520 100070487 100071122 100072691 100078379 100080232 100080844 201003462