Compumedics Usa, Ltd Compumedics E-Series Digital Amplifier System part number 8008-0001-01 and 8008-0001-02, manufactured by Compumedics Limited, Australia Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Compumedics E-Series Digital Amplifier System part number 8008-0001-01 and 8008-0001-02, manufactured by Compumedics Limited, Australia
Brand
Compumedics Usa, Ltd
Lot Codes / Batch Numbers
All codes
Products Sold
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Compumedics Usa, Ltd is recalling Compumedics E-Series Digital Amplifier System part number 8008-0001-01 and 8008-0001-02, manufacture 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