Compumedics E-Series Digital Amplifier System part number 8008-0001-01 and 8008-0001-02, manufactured by Compumedics Limited, Australia
FDA Recall Z-0652-05 · Posted 2005-03-24
Recalling FirmCompumedics Usa, Ltd
Recall StatusTerminated
Product CodeGWQ
Date Initiated2005-02-24
Date Terminated2007-12-07
Product Quantity1376 units
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.
Firm Action
The firm initiated the recall on February 24, 2005 via letter with return response post card.
Root Cause
Other
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.