FDA Medical Device Recalls (openFDA)
Custom Ultrasonics, Inc.: System 83 Plus Washer-Disinfector, Endoscope use, DOS based system, Custom Ultrasonics Inc., Buckingham, PA
- Recall number
- Z-1182-2008
- Recalling firm
- Custom Ultrasonics, Inc.
- Product
- System 83 Plus Washer-Disinfector, Endoscope use, DOS based system, Custom Ultrasonics Inc., Buckingham, PA
- Status
- Terminated
- Initiated
- 2008-02-11
- Posted
- 2008-03-07
- Terminated
- 2009-09-03
- 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
- Lot, serial or model codes
- All Serial Numbers
- 510(k) numbers
- ["K983017"]
- PMA numbers
- not on file
- Product code
- KOG
- Firm FEI
- 2523209
- Firm city
- Ivyland
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28