Recall Z-0652-05 ยท GWQ Full-Montage Standard Electroencephalograph
Compumedics Usa, Ltd
Compumedics E-Series Digital Amplifier System part number 8008-0001-01 and 8008-0001-02, manufactured by Compumedics Limited, Australia
| Date | Mar 24, 2005 (initiated Feb 24, 2005) |
| Status | Terminated |
| Reason | Under specific conditions, the housing of the pulse oximeter contected to the amplifier can become excessively warm causing a burn upon contact with skin. |
| Root cause | Other |
| Action | The firm initiated the recall on February 24, 2005 via letter with return response post card. |
| Quantity | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K000068 | COMPUMEDICS E-SERIES EEG SYSTEM Compumedics Neuro Science Pty , Ltd., Mar 13, 2000 |