Z-1408-06

Amsco Sonic Energy Console, Part Nos.: B602047470, P080000002, P080000003, B018905015, B018905016...

Name: Z-1408-06 Amsco Sonic Energy Console, Part Nos.: B602047470, P080000002, P080000003, B018905015, B018905016...
Creator: Steris Corporation
Published: 2006-06-22
License: https://open.fda.gov/license/

STERIS Corporation / initiated 2006-06-22 / Terminated / root cause: manufacturing process

FDA source

Steris Corporation began a recall of Amsco Sonic Energy Console, Part Nos.: B602047470, P080000002, P080000003, B018905015, B018905016, B018905017, B018905018, B018905JAE, B018905JAESS... on 2006-06-22. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1408-06
Status: Terminated
Initiated: 2006-06-22
Posted: 2006-08-25
Terminated: 2007-01-08
Recalling firm: STERIS Corporation
Product: Amsco Sonic Energy Console, Part Nos.: B602047470, P080000002, P080000003, B018905015, B018905016, B018905017, B018905018, B018905JAE, B018905JAESS, B018905JAESSI, B018905JAG, B018905JAGSS
Product code: FLG Cleaner, Ultrasonic, Medical Instrument
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.
Root cause tag: manufacturing process
FDA 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 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.
Product codes and lots: All units bearing serial numbers 0432000018 to 0403105051.

Product code FLG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)