Z-1187-2013Class II

Rad-8 Pulse Oximeters The Rad-8 family of pulse oximeters and accessories are indicated for the continuous...

Name: Z-1187-2013 Rad-8 Pulse Oximeters The Rad-8 family of pulse oximeters and accessories are indicated for the continuous...
Creator: Masimo Corporation
Published: 2013-03-13
License: https://open.fda.gov/license/

Masimo Corporation / initiated 2013-03-13 / Terminated / root cause: design

FDA source

Masimo Corporation began a recall of Rad-8 Pulse Oximeters The Rad-8 family of pulse oximeters and accessories are indicated for the continuous, noninvasive monitoring of functional oxygen... on 2013-03-13. FDA classified it as Class II and gives the reason as "Masimo has identified a very small number (0.02%) of Rad-8 devices with 20-pin patient cable connector that, when moved, can power off without the operator pressing the power button". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1187-2013
Classification: Class II
Status: Terminated
Initiated: 2013-03-13
Posted: 2013-04-29
Terminated: 2015-06-10
Recalling firm: Masimo Corporation
Product: Rad-8 Pulse Oximeters The Rad-8 family of pulse oximeters and accessories are indicated for the continuous, noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor).
Product code: DQA Oximeter
Reason for recall: Masimo has identified a very small number (0.02%) of Rad-8 devices with 20-pin patient cable connector that, when moved, can power off without the operator pressing the power button.
Root cause tag: design
FDA root cause: Device Design
Action: Masimo Corporation sent an Urgent Recall Notification letter dated March 8, 2013, to all affected customers The letter identified the product the problem and the action needed to be taken by the customer. 1.Customers were instructed to please promptly remove all Rad-8 device(s) from use and your inventory and segregate these devices. 2. Please call 1-800-326-4890 and select option 2 for Technical Services. Determine with Technical Services whether you will return the affected device(s) to Masimo for repair or if eligible, receive a repair kit. If you will return the device(s) for repair, obtain a Return Material Authorization Number (RMA number). 3. Complete the Tracking/Verification Form in Attachment 2 and fax it to Masimo at 1-949-297-7700, even if you do not have or intend to use the affected device(s). 4. If you are eligible and intend to repair units onsite fax the completed original form in Attachment 2 to Masimo at 1-949-297-7700. 5. If you have elected to return the affected device(s), and have an RMA number include the completed original Form in Attachment 2 with the returned device(s) and indicate the RMA number on the outside of the return-shipping box. We apologize for the inconvenience. Please be assured that Masimo is committed to consistently providing high quality products and services to you, our customers. We thank you for your patience and cooperation while we actively work to resolve this issue. . .
Quantity in commerce: 42,908 units
Distribution: Worldwide Distribution - USA (nationwide) including the countries of Africa, Asia, Australia/New Zealand, Europe, Canada, Latin America, and Middle East / SW Asia.
Product codes and lots: Catalog Number 9190 9193 9191 9192 9212 9213 9218 9219 9224 9282 9285 2883 9194

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1187-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1187-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-08	2013-04-29

Product code DQA

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)