Z-0933-05

Radical Handheld Pulse Oximeter

Name: Z-0933-05 Radical Handheld Pulse Oximeter
Creator: Masimo Corporation
Published: 2005-06-10
License: https://open.fda.gov/license/

Masimo Corporation / initiated 2005-06-10 / Terminated

FDA source

Masimo Corporation began a recall of Radical Handheld Pulse Oximeter on 2005-06-10. The reason FDA records is "Speaker component failure resulting in ceasation of an audible alarm even though the condition continues that caused the alarm". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0933-05
Status: Terminated
Initiated: 2005-06-10
Posted: 2005-06-25
Terminated: 2008-06-17
Recalling firm: Masimo Corporation
Product: Radical Handheld Pulse Oximeter
Product code: DQA Oximeter
Reason for recall: Speaker component failure resulting in ceasation of an audible alarm even though the condition continues that caused the alarm.
FDA root cause: Other
Action: Recall was by letter to all customers who received units made before 12/11/01. They are to return for repair or have them fixed by an Authorized Masimo Service Representative.
Quantity in commerce: 8,110
Distribution: Nationwide and Korea, Hong Kong, Canada, New Zealand, Thailand, Argentina, Portugal, Malaysia, Ireland, Australia, japan, France, El Salvador, South Africa, UAE-Saudi Arabia, Germany, Mexico, Unitied Kingdom, Singapore, Germany, Kuwait, Chile, Spain, Iceland, Italy, Poland, Sweden, Norway, Venezuela, Lithuania, Czech Republic, Belgium, Neterlands, Austria, Switzerland, Egypt, Greece, France Taiwan.
Product codes and lots: Serial numbers-- P3027 through P3148 and serial numbers less than or equal to 102999.

Product code DQA

K992340Class IIMasimo Set Radical Pulse Oximeter with Satshare, Masimo Lnop -Adt-Adult/pediatric Disposable Sensor, Masimo Lnop -Pdt-PeMasimo Corp. / cleared 1999-10-08

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)