| | Class 2 Device Recall Compumedics |  |
| Date Initiated by Firm | February 24, 2005 |
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| Date Posted | March 24, 2005 |
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| Recall Status1 |
Terminated 3 on December 07, 2007 |
| Recall Number | Z-0653-05 |
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| Recall Event ID |
31197 |
| Product Classification |
Full-Montage Standard Electroencephalograph - Product Code GWQ
|
| Product | Nonin Xpod Oximeter model numbers 3011 and 3012, distributed for use with the Compumedics E-Series Digital Amplifier. |
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| Code Information |
All codes |
| FEI Number |
3002716534
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Recalling Firm/
Manufacturer |
Compumedics Usa, Ltd
7850 Paseo Del Norte
El Paso TX 79912
|
Manufacturer 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. |
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FDA Determined
Cause 2 | Other |
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| Action | The firm initiated the recall on February 24, 2005 via letter with return response post card. |
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| Quantity in Commerce | 1376 units |
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| 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, and the United Kingdom. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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