Recalls / —
—#46705
Product
Amsco Sonic Energy Console, Part Nos.: B602047470, P080000002, P080000003, B018905015, B018905016, B018905017, B018905018, B018905JAE, B018905JAESS, B018905JAESSI, B018905JAG, B018905JAGSS
- FDA product code
- FLG — Cleaner, Ultrasonic, Medical Instrument
- Device class
- Class 1
- Medical specialty
- General Hospital
- Affected lot / code info
- All units bearing serial numbers 0432000018 to 0403105051.
Why it was recalled
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.
Root cause (FDA determination)
Other
Action the firm took
The firm sent out a certified letter to all affected consignees alerting them to problems with the device on 6/22/06.
Recalling firm
- Firm
- Steris Corporation
- Address
- 2720 Gunter Park Dr E, Montgomery, Alabama 36109-1410
Distribution
- Distribution pattern
- Worldwide USA and countries of Japan, Canada, Hong Kong, Korea, Lebanon, Qatar, Poland, Russia, Saudi Arabia, Singapore, Taiwan, Germany, Northern Mariana Islands, and Malaysia.
Timeline
- Recall initiated
- 2006-06-22
- Posted by FDA
- 2006-08-25
- Terminated
- 2007-01-08
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #46705. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.