Class 2 Device Recall System 83 Plus WasherDisinfector

• Date Initiated by Firm: February 11, 2008
• Date Posted: March 07, 2008
• Recall Status: Terminated on September 03, 2009
• Recall Number: Z-1182-2008
• Recall Event ID: 46877
• 510(K)Number: K983017
• Product Classification: Endoscope Washer-Disinfector - Product Code KOG
• Product: System 83 Plus Washer-Disinfector, Endoscope use, DOS based system, Custom Ultrasonics Inc., Buckingham, PA
• Code Information: All Serial Numbers
• Recalling Firm/ Manufacturer: Custom Ultrasonics, Inc.; 144 Railroad Dr; Ivyland PA 18974-1449
• For Additional Information Contact: Bernd D. Ascher; 215-364-1477
• Manufacturer Reason for Recall: Inadvertent selection of the "wash" cycle
• FDA Determined Cause: Labeling design
• Action: The recalling firm issued a Product Correction letter dated 2/11/08 to its customers informing them of the problem and the correction choices. The letter states that a key cover is available to reduce the error in the future and will be provided to each users upon return of the recall letter notification questionnaire.
• Quantity in Commerce: 3,190 units
• Distribution: Worldwide; USA medical facilities and physicians and Canada

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.

• 510(K) Database: 510(K)s with Product Code = KOG and Original Applicant = CUSTOM ULTRASONICS