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U.S. Department of Health and Human Services

Safety

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STERIS Amsco Sonic Energy Cleaner and Amsco Sonic Energy Console Urgent Product Correction Letter June 2006

The following information is from Steris, Inc. Contact the company for a copy of any referenced enclosures.

 


Urgent Product Correction

June 21, 2006

ATTN: MATERIALS MANAGER, PURCHASING MANAGER, AND RISK MANAGER.

RE: Field Correction of STERIS Amsco Sonic Energy Cleaner and Amsco Sonic Energy Console

Dear Material, Purchasing and Risk Managers,

STERIS is initiating a field correction of the Amsco Sonic Energy Cleaner and the Amsco Sonic Energy Console manufactured from November 2000 until January 2005. The affected product range covers units bearing serial numbers 0432000018 to 0403105051. The serial number is located on the product identification plate, located on the base of the unit, beneath the front door.

Our records indicate that your facility has purchased a STERIS Amsco Sonic Energy Cleaner and/or an Amsco Sonic Energy Console. STERIS has learned of a potential fire issue with the Sonic Energy Console and Sonic Energy Cleaner units made between November 2000 and January 2005. This letter is to inform you that STERIS has initiated a field correction.

Description of the problem - The lid switch cable wiring harness in these units is located in a position which is susceptible to water damage to electrical connections. If this situation occurs, it can cause overheating of the electrical system in the unit and lead to damage of the wiring harness(s) resulting in smoking, sparking, and fire.

Please notify your staff of this important issue and instruct them to follow proper safety precautions such as allowing the instrument tray to drain fully before moving to the next cleaning station to prevent water from contacting the electrical wiring while using this device.

In the event of overheating in the electrical system and damage of the wiring harness, the immediate effect is that the unit becomes unusable and must be repaired. In the event of an incident, there is a potential risk of staff personnel in cleaning area sustaining smoke inhalation. The electrical system is self enclosed within stainless steel on all sides with a galvanized steel back plate. The risk of injury to resident patients is low if a Sonic Cleaner or Sonic Console is not located in patient care areas.

Description of field correction - A STERIS technician will visit your account to replace the wire harness and associated components in the affected units. For further information or if you have questions regarding the servicing of your unit, please contact STERIS Field Service Dispatch at 1-800-288-2805. Units made after January 2005 have the wiring harness routed in a manner which alleviates water damage and have electrical connections that are water resistant and are not included in this field correction.

We apologize for any inconvenience this matter may cause you. If you have questions regarding this matter, please call Holly Wright Lee at 440-392-7019 or 1-800-548-4873 ext. 27019.