DRE Medical Group Inc Recall 92448
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.
DRE Medical Group Inc Recall 92448 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2025-2023 |
| Event ID | 92448 |
| Event 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. |
| Product Type | Devices |
| Distribution | US: CA, FL |
| Quantity | 22 units |
| Recall 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. |
| Device Classification | 20230705 |
| Device Code Info | 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 |
| Center Classification Date | 20230628 |
| Recall Initiation Date | 20230515 |
| Recalling Firm | DRE Medical Group Inc |
| Initial Notification | |
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