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Class 2 Device Recall Amsco Ultrasonic instrument cleaner |
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| Date Initiated by Firm |
June 22, 2006 |
| Date Posted |
August 25, 2006 |
| Recall Status1 |
Terminated 3 on January 08, 2007 |
| Recall Number |
Z-1408-06 |
| Recall Event ID |
35737 |
| Product Classification |
Ultrasonic instrument cleaner - Product Code FLG
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| Product |
Amsco Sonic Energy Console, Part Nos.: B602047470, P080000002, P080000003, B018905015, B018905016, B018905017, B018905018, B018905JAE, B018905JAESS, B018905JAESSI, B018905JAG, B018905JAGSS |
| Code Information |
All units bearing serial numbers 0432000018 to 0403105051. |
Recalling Firm/
Manufacturer |
Steris Corporation
2720 Gunter Park Dr E
Montgomery AL 36109-1410
|
| For Additional Information Contact |
Kenneth P. Finch
334-274-5183
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Manufacturer Reason
for Recall |
Smoke, sparking and fire hazard-Units manufactured between November 2000 and January 2005 are susceptible to water damage at the lid switch cable wiring harness, which may result in smoking, sparking, and fire.
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FDA Determined
Cause 2 |
Other |
| Action |
The firm sent out a certified letter to all affected consignees alerting them to problems with the device on 6/22/06. |
| Quantity in Commerce |
353 units |
| Distribution |
Worldwide USA and countries of Japan, Canada, Hong Kong, Korea, Lebanon, Qatar, Poland, Russia, Saudi Arabia, Singapore, Taiwan, Germany, Northern Mariana Islands, and Malaysia. |
| 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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