Device recall: Masimo SET uSpO2 Cable The Masimo SET uSpO2 Pulse Oximetry Cable is an in-line cable that provides continuous…
Class II FDA enforcement event 69504. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Firm has identified a small number of Oximetry Cables with crossed-internal wires. The effect on performance when these wires are crossed is that when a low SpO2 value is measured, a high SpO2 value would be displayed on the monitoring device. Additionally when a high SpO2 value is measured, a low SpO2 value would be displayed on the monitoring device.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Masimo Corporation started this device recall on 30 Sep 2014. The firm address in the FDA record is in Irvine, CA. FDA put the recall in Class II. FDA event 69504 has 1 product record. The first FDA enforcement report date is 19 Nov 2014. The record gives the status Terminated, with the termination date 28 Mar 2016.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Worldwide distribution including; nationwide (U.S. and Puerto Rico) and the countries of Argentina, Austria, Brazil, Canada, China, Denmark, France, Gernany, Hong Kong, India, Italy, Japan, Jordan,…
Recalling firm
Masimo Corporation, Irvine, CA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0213-2015 | Masimo SET uSpO2 Cable The Masimo SET uSpO2 Pulse Oximetry Cable is an in-line cable that provides continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (Sp02) and pulse rate when installed in a compatible OEM host system. Shipping/Package: All Pulse Oximetry cables are shipped… | 21,754 units (21,222) in the U.S. and Puerto Rico) | Class II | Terminated | 19 Nov 2014 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2014
- 1,176
- Share of these events in Class II
- 91%
- Product records in this event
- 1Median of the firm: 2
- Events of the firm on the register
- 6
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 20 Feb 2026 | Radius VSM ECG pre-connected Set, REF: 4842, 4695 | Device | Class II | 2 |
| 15 Feb 2024 | Masimo Rad-G, Pulse Oximeter with temperature (W/Sensor), REF:9210, Rx Only, | Device | Class II | 4 |
| 21 Apr 2023 | Masimo RD Set TC-I SpO2 Adult Reusable Ear Sensor, REF: 4053 | Device | Class II | 4 |
| 28 Oct 2015 | rainbow Reusable Sensors. RAINBOW DCI-DC3, SpO2/SpCO/SpMet, Part No. 2201; RAINBOW DCI-dc8, SpO2/SpCO/SpMet, Part No. 24 | Device | Class II | 1 |
| 13 Mar 2013 | Rad-8 Pulse Oximeters The Rad-8 family of pulse oximeters and accessories are indicated for the continuous, noninvasive | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-0213-2015The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 69504. https://recallregister.com/fda/ii/69504/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Worldwide distribution including; nationwide (U.S. and Puerto Rico) and the countries of Argentina, Austria, Brazil, Canada, China, Denmark, France, Gernany, Hong Kong, India, Italy, Japan, Jordan,…
- What quantity of product is in FDA event 69504?
- The FDA record gives this quantity:
21,754 units (21,222) in the U.S. and Puerto Rico)
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2014 have the same class?
- 91% of the 1,176 device events that started in 2014 are in Class II.