Rainbow DC-I-DC Pulse CO-Oximeter Sensor used with the Masimo SET Rad 57 Pulse CoOximeter
FDA device recall Z-0661-06 · posted 2006-03-18 · Terminated
Recall details
- Recalling firm
- Masimo Corporation
- Reason for recall
- Internal testing revealed that some of the sensors might not meet the accuracy specifications of : 2% for SpO2 and of: 3% for SpCO, due to the tolerance of one of the emitter LED's used in the calculation ofSpO2 and SpCO. The SpO2 reading may have a negative bias of up to 1 % and the SpCO reading may have a negative bias of up to 4%.
- Action taken
- Masimo notified all customers by letter sent via Federal Express who were shipped Rainbow DC- I-DC sensors to return them to Masimo for repair or replacement. A Tracking/Verification form will be mailed with the letter to be faxed back to Masimo. Masimo will repair or replace the returned units and return them back to the customer.
- Root cause
- Other
- Status
- Terminated
- Product code
- DQA
- Quantity affected
- 321
- Distribution
- Nationwide and Belgium, Canada, France, Germany, Italy, South Korea, new Zealand, Slovenia, Spain, Sweden, Switzerland, and United Arab Emirates
- Date initiated
- 2006-02-02
- Date posted
- 2006-03-18
- Date terminated
- 2008-06-17
- Location
- Irvine, CA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MASIMO SET RAD 57 PULSE CO-OXIMETER (K042536) | Masimo Corporation | 2005-01-19 |