Compumedics E-Series Digital Amplifier System part number 8008-0001-01 and 8008-0001-02, manufactured by Compumedics Lim
FDA device recall Z-0652-05 · posted 2005-03-24 · Terminated
Recall details
- Recalling firm
- Compumedics Usa, Ltd
- 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.
- Action taken
- The firm initiated the recall on February 24, 2005 via letter with return response post card.
- Root cause
- Other
- Status
- Terminated
- Product code
- GWQ
- Quantity affected
- 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, Pillipp
- Date initiated
- 2005-02-24
- Date posted
- 2005-03-24
- Date terminated
- 2007-12-07
- Location
- El Paso, TX
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| COMPUMEDICS E-SERIES EEG SYSTEM (K000068) | Compumedics Neuro Science Pty , Ltd. | 2000-03-13 |