Z-0653-05

Nonin Xpod Oximeter model numbers 3011 and 3012, distributed for use with the Compumedics E-Series Digital...

Name: Z-0653-05 Nonin Xpod Oximeter model numbers 3011 and 3012, distributed for use with the Compumedics E-Series Digital...
Creator: Compumedics Usa, Ltd
Published: 2005-02-24
License: https://open.fda.gov/license/

Compumedics USA, Inc. / initiated 2005-02-24 / Terminated

FDA source

Compumedics Usa, Ltd began a recall of Nonin Xpod Oximeter model numbers 3011 and 3012, distributed for use with the Compumedics E-Series Digital Amplifier on 2005-02-24. The reason FDA records is "Under specific conditions, the housing of the pulse oximeter contected to the amplifier can become excessively warm causing a burn upon contact with skin". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0653-05
Status: Terminated
Initiated: 2005-02-24
Posted: 2005-03-24
Terminated: 2007-12-07
Recalling firm: Compumedics USA, Inc.
Product: Nonin Xpod Oximeter model numbers 3011 and 3012, distributed for use with the Compumedics E-Series Digital Amplifier.
Product code: GWQ Full-Montage Standard Electroencephalograph
Reason for recall: Under specific conditions, the housing of the pulse oximeter contected to the amplifier can become excessively warm causing a burn upon contact with skin.
FDA root cause: Other
Action: The firm initiated the recall on February 24, 2005 via letter with return response post card.
Quantity in commerce: 1376 units
Distribution: Product was distributed nationwide and to the following foreign countries: Australia, Canada, Greece, Hong Kong, Hungary, India, Iran, Israel, Italy, Japan, Malaysia, Netherlands, New Zealand, Pillippines, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Taiwan, Thailand, Turkey, and the United Kingdom.
Product codes and lots: All codes

Product code GWQ

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)