Recall Z-0661-06 ยท DQA Oximeter
Masimo Corporation
Rainbow DC-I-DC Pulse CO-Oximeter Sensor used with the Masimo SET Rad 57 Pulse CoOximeter
| Date | Mar 18, 2006 (initiated Feb 2, 2006) |
| Status | Terminated |
| Reason | 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%. |
| Root cause | Other |
| Action | 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. |
| Quantity | 321 |
| Distribution | Nationwide and Belgium, Canada, France, Germany, Italy, South Korea, new Zealand, Slovenia, Spain, Sweden, Switzerland, and United Arab Emirates |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042536 | MASIMO SET RAD 57 PULSE CO-OXIMETER Masimo Corporation, Jan 19, 2005 |