Recall Z-0338-2016 ยท DQA Oximeter
Masimo Corporation
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), arteri
| Date | Nov 25, 2015 (initiated Oct 28, 2015) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Finished device change control |
| 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. |
| Quantity | 3476 units total (3322 units in US) |
| Distribution | Worldwide Distribution - US (nationwide) and Internationally to Australia, Costa Rica, France, Germany, Kuwait, Martinique, Netherlands, Norway, South Korea, and Turkey. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080238 | MASIMO RAINBOW SET RADICAL 7 PULSE CO-OXIMETER, MASIMO RAINBOW SET RAD 87 PULSE CO-OXIMETER Masimo Corporation, May 12, 2008 |