PHILIPS BATTERY, V60 14.4V, 11.0 Ah, 163 Wh, REF 1076374(1058272), LOT M94663-P1 - Product Usage:...
FDA Device Recall #Z-1137-2021 — Class II — January 6, 2021
Recall Summary
| Recall Number | Z-1137-2021 |
| Classification | Class II — Moderate risk |
| Date Initiated | January 6, 2021 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Respironics California, LLC |
| Location | Carlsbad, CA |
| Product Type | Devices |
| Quantity | 94 batteries |
Product Description
PHILIPS BATTERY, V60 14.4V, 11.0 Ah, 163 Wh, REF 1076374(1058272), LOT M94663-P1 - Product Usage: The ventilator is intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
Reason for Recall
Due to unqualified "design verification" batteries being shipped to customers.
Distribution Pattern
U.S. Nationwide distribution including in the states of FL, GA, IA, IA, IL. IL, MN, MO, NC, ND, OH, TX, TX and UT.
Lot / Code Information
Battery Model/Part Number: 1076374 Lot Code: M94663-P1
Other Recalls from Respironics California, LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0909-2022 | Class I | Philips Respironics V680 Ventilator (All Models... | Feb 28, 2022 |
| Z-0907-2022 | Class I | Philips Respironics V60 Ventilator (All Models,... | Feb 28, 2022 |
| Z-0908-2022 | Class I | Philips Respironics V60 Plus Ventilator (All Mo... | Feb 28, 2022 |
| Z-0662-2022 | Class I | Philips Respironics V60 Ventilator Part Number ... | Jan 24, 2022 |
| Z-0663-2022 | Class I | Philips Respironics V60 Plus Ventilator Part Nu... | Jan 24, 2022 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.