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Terminated

System 83 Plus Washer-Disinfector, Endoscope use, DOS based system, Custom Ultrasonics Inc., Buckingham, PA

FDA Recall Z-1182-2008 · Posted 2008-03-07

Recalling FirmCustom Ultrasonics, Inc.
Recall StatusTerminated
Product CodeKOG
Date Initiated2008-02-11
Date Terminated2009-09-03
Product Quantity3,190 units

Reason for Recall

Inadvertent selection of the "wash" cycle

Firm 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.

Root Cause

Labeling design

Distribution Pattern

Worldwide; USA medical facilities and physicians and Canada

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K983017MODIFICATION TO SYSTEM 83 PLUSCustom Ultrasonics · 1998-09-22

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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