CLASS II Device recall · Reported 8 May 2013 · FDA Enforcement Report
Rad-8 Pulse Oximeters The Rad-8 family of pulse oximeters recalled
Masimo is recalling Rad-8 Pulse Oximeters The Rad-8 family of pulse oximeters and accessories are indicated, distributed nationwide in the US. The recall was initiated on 13 Mar 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1187-2013
- FDA event ID
- 64812
- Recalling firm
- Masimo, Irvine, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Mar 2013
- FDA classified
- 29 Apr 2013
- Reported
- 8 May 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Patient Monitors
Timeline
| 13 Mar 2013 | Recall initiated by company | |
| 29 Apr 2013 | Classified by FDA | +47 days |
| 8 May 2013 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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).
Where it was distributed
Worldwide Distribution - USA (nationwide) including the countries of Africa, Asia, Australia/New Zealand, Europe, Canada, Latin America, and Middle East / SW Asia.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Catalog Number 9190 9193 9191 9192 9212 9213 9218 9219 9224 9282 9285 2883 9194
Where was it sold?
Worldwide Distribution - USA (nationwide) including the countries of Africa, Asia, Australia/New Zealand, Europe, Canada, Latin America, and Middle East / SW Asia.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Masimo
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Radius VSM Disposable NIBP Cuff recalled by Masimo | Masimo | Device Malfunction | Nationwide |
| Device | CLASS II | Radius VSM ECG pre-connected Set recalled by Masimo | Masimo | Device Malfunction | Nationwide |
| Device | CLASS II | Rad-G, Pulse Oximeter (W/Patient Cable) recalled by Masimo | Masimo | Other | Nationwide |
| Device | CLASS II | Rad-G, Pulse Oximeter with temperature (W/Sensor) recalled by Masimo | Masimo | Temperature Abuse | Nationwide |
| Device | CLASS II | Rad-G, Pulse Oximeter (W/Patient Cable) recalled by Masimo | Masimo | Other | Nationwide |
Other Patient Monitors recalls
All 1,022| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS III | Passport Series Patient Monitor recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS III | T1 Patient Monitor recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS III | cPM Series Patient Monitor recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS III | BeneVision Series Telemetry Monitor recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS III | Panorama and Telemetry Monitoring System recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |