rainbow Reusable Sensors. RAINBOW DCI-DC3, SpO2/SpCO/SpMet, Part No. 2201; RAINBOW DCI-dc8, SpO2/SpCO/SpMet, Part No. 2407; RAINBOW DCI, SpO2/SpCO/SpMet, Part No. 2696; RAINBOW DCIP, PED, SpO2/SpCO/SpMet, Part No. 2697. rainbow reusable sensors are indicated for spot check or continuous non-invasive monitoring of arterial saturation (SpO2), arterial carboxyhemoglobin saturation (SpCO), arterial methemoglobin (SpMet), and pulse rate.
FDA Recall Z-0338-2016 · Posted 2015-11-25
Recalling FirmMasimo Corporation
Recall StatusTerminated
Product CodeDQA
Date Initiated2015-10-28
Date Terminated2016-05-18
Product Quantity3476 units total (3322 units in US)
Reason for Recall
These sensors were manufactured with incompatible configurations. This could result in sensors that will provide either no readings or inaccurate readings for the SpCO and SpMet parameters.
Firm Action
Masimo sent an Urgent Product Recall letter on October 28, 2015, to all affected customers to inform them that Masimo has identified specific lots of sensors that were manufactured with incompatiable configurations. The letter provides the customers with the problems identified and the actions to be taken. Customers are instructed to complete the tracking/verification form and email to Masimo. Customers with questions were instructed to contact Masimo Technical Services at http://Service.Masimo.com. For questions regarding this recall call 949-297-7000.
Root Cause
Finished device change control
Distribution Pattern
Worldwide Distribution - US (nationwide) and Internationally to Australia, Costa Rica, France, Germany, Kuwait, Martinique, Netherlands, Norway, South Korea, and Turkey.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.