Rad-8 Pulse Oximeters The Rad-8 family of pulse oximeters and accessories are indicated for t...
FDA Device Recall #Z-1187-2013 — Class II — March 13, 2013
Recall Summary
| Recall Number | Z-1187-2013 |
| Classification | Class II — Moderate risk |
| Date Initiated | March 13, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Masimo Corporation |
| Location | Irvine, CA |
| Product Type | Devices |
| Quantity | 42,908 units |
Product Description
Rad-8 Pulse Oximeters The Rad-8 family of pulse oximeters and accessories are indicated for the continuous, noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor).
Reason for Recall
Masimo has identified a very small number (0.02%) of Rad-8 devices with 20-pin patient cable connector that, when moved, can power off without the operator pressing the power button.
Distribution Pattern
Worldwide Distribution - USA (nationwide) including the countries of Africa, Asia, Australia/New Zealand, Europe, Canada, Latin America, and Middle East / SW Asia.
Lot / Code Information
Catalog Number 9190 9193 9191 9192 9212 9213 9218 9219 9224 9282 9285 2883 9194
Other Recalls from Masimo Corporation
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1539-2024 | Class II | Masimo Rad-G, Pulse Oximeter (W/Patient Cable),... | Feb 15, 2024 |
| Z-1536-2024 | Class II | Masimo Rad-G, Pulse Oximeter with temperature (... | Feb 15, 2024 |
| Z-1538-2024 | Class II | Masimo Rad-G, Pulse Oximeter (W/Patient Cable),... | Feb 15, 2024 |
| Z-1537-2024 | Class II | Masimo Rad-G, Pulse Oximeter (W/Sensor), REF:98... | Feb 15, 2024 |
| Z-1986-2023 | Class II | Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF... | Apr 21, 2023 |
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.