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Terminated

Rainbow DC-I-DC Pulse CO-Oximeter Sensor used with the Masimo SET Rad 57 Pulse CoOximeter

FDA Recall Z-0661-06 · Posted 2006-03-18

Recalling FirmMasimo Corporation
Recall StatusTerminated
Product CodeDQA
Date Initiated2006-02-02
Date Terminated2008-06-17
Product Quantity321

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%.

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide and Belgium, Canada, France, Germany, Italy, South Korea, new Zealand, Slovenia, Spain, Sweden, Switzerland, and United Arab Emirates

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K042536MASIMO SET RAD 57 PULSE CO-OXIMETERMasimo Corporation · 2005-01-19

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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