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U.S. Department of Health and Human Services

Class 2 Device Recall rainbow Reusable Sensors

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 Class 2 Device Recall rainbow Reusable Sensorssee related information
Date Initiated by FirmOctober 28, 2015
Date PostedNovember 25, 2015
Recall Status1 Terminated 3 on May 18, 2016
Recall NumberZ-0338-2016
Recall Event ID 72626
510(K)NumberK080238 
Product Classification Oximeter - Product Code DQA
Productrainbow 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.
Code Information 2201 2407 2696 2697 
Recalling Firm/
Manufacturer		 Masimo Corporation
Forty Parker
Irvine CA 92618
For Additional Information Contact
949-297-7000
Manufacturer 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.
FDA Determined
Cause 2		Finished device change control
ActionMasimo 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 in Commerce3476 units total (3322 units in US)
DistributionWorldwide Distribution - US (nationwide) and Internationally to Australia, Costa Rica, France, Germany, Kuwait, Martinique, Netherlands, Norway, South Korea, and Turkey.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = DQA
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