Recall Z-1182-2008 ยท KOG
Custom Ultrasonics, Inc.
System 83 Plus Washer-Disinfector, Endoscope use, DOS based system, Custom Ultrasonics Inc., Buckingham, PA
| Date | Mar 7, 2008 (initiated Feb 11, 2008) |
| Status | Terminated |
| Reason | Inadvertent selection of the "wash" cycle |
| Root 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 | 3,190 units |
| Distribution | Worldwide; USA medical facilities and physicians and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K983017 | MODIFICATION TO SYSTEM 83 PLUS Custom Ultrasonics, Sep 22, 1998 |