System 83 Plus Washer-Disinfector, Endoscope use, DOS based system, Custom Ultrasonics Inc., Buckingham, PA
FDA device recall Z-1182-2008 · posted 2008-03-07 · Terminated
Recall details
- Recalling firm
- Custom Ultrasonics, Inc.
- Reason for recall
- Inadvertent selection of the "wash" cycle
- Action taken
- 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
- Status
- Terminated
- Product code
- KOG
- Quantity affected
- 3,190 units
- Distribution
- Worldwide; USA medical facilities and physicians and Canada
- Date initiated
- 2008-02-11
- Date posted
- 2008-03-07
- Date terminated
- 2009-09-03
- Location
- Ivyland, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO SYSTEM 83 PLUS (K983017) | Custom Ultrasonics | 1998-09-22 |