Recall Z-1408-06 ยท FLG Cleaner, Ultrasonic, Medical Instrument
Steris Corporation
Amsco Sonic Energy Console, Part Nos.: B602047470, P080000002, P080000003, B018905015, B018905016, B018905017, B018905018, B018905JAE, B018905JAESS, B018905JAESSI, B018905JAG, B018905JAGSS
| Date | Aug 25, 2006 (initiated Jun 22, 2006) |
| Status | Terminated |
| Reason | 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 | 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.