Z-0338-2016Class II

rainbow Reusable Sensors. RAINBOW DCI-DC3, SpO2/SpCO/SpMet, Part No. 2201; RAINBOW DCI-dc8, SpO2/SpCO/SpMet...

Name: Z-0338-2016 rainbow Reusable Sensors. RAINBOW DCI-DC3, SpO2/SpCO/SpMet, Part No. 2201; RAINBOW DCI-dc8, SpO2/SpCO/SpMet...
Creator: Masimo Corporation
Published: 2015-10-28
License: https://open.fda.gov/license/

Masimo Corporation / initiated 2015-10-28 / Terminated / root cause: manufacturing process

FDA source

Masimo Corporation began a recall of 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... on 2015-10-28. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0338-2016
Classification: Class II
Status: Terminated
Initiated: 2015-10-28
Posted: 2015-11-25
Terminated: 2016-05-18
Recalling firm: Masimo Corporation
Product: 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.
Product code: DQA Oximeter
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and lots: 2201 2407 2696 2697

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0338-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0338-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-02	2015-11-25

Product code DQA

K080238Class IIMasimo Rainbow Set Radical 7 Pulse Co-Oximeter, Masimo Rainbow Set Rad 87 Pulse Co-OximeterMasimo Corporation / cleared 2008-05-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)