Compumedics Usa, Ltd Nonin Xpod Oximeter model numbers 3011 and 3012, distributed for use with the Compumedics E-Series Digital Amplifier. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Nonin Xpod Oximeter model numbers 3011 and 3012, distributed for use with the Compumedics E-Series Digital Amplifier.
Brand
Compumedics Usa, Ltd
Lot Codes / Batch Numbers
All codes
Products Sold
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Compumedics Usa, Ltd is recalling Nonin Xpod Oximeter model numbers 3011 and 3012, distributed for use with the Compumedics E-Series D due to Under specific conditions, the housing of the pulse oximeter contected to the amplifier can become excessively warm causing a burn upon contact with s. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Under specific conditions, the housing of the pulse oximeter contected to the amplifier can become excessively warm causing a burn upon contact with skin.
Recommended Action
Per FDA guidance
The firm initiated the recall on February 24, 2005 via letter with return response post card.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026