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Recall Observatory FDA recall evidence

Device product

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.

Z-2025-2023

May 15, 2023

Class II

Product summary

Firm
DRE Medical Group Inc
Event
Event 92448
Status
Ongoing
Classification
Class II
Quantity
22 units
Official record key
device-enforcement:Z-2025-2023

Official wording

Reason: 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.

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

Distribution pattern: US: CA, FL

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.