FDA Medical Device Recalls (openFDA)
Custom Ultrasonics, Inc.: 83 plus Mini-flex with accessory crate, Custom Ultrasonics, Inc.
- Recall number
- Z-0770-2007
- Recalling firm
- Custom Ultrasonics, Inc.
- Product
- 83 plus Mini-flex with accessory crate, Custom Ultrasonics, Inc.
- Status
- Terminated
- Initiated
- 2005-12-12
- Posted
- 2007-05-04
- Terminated
- 2013-02-20
- Reason
- The device was marketed without a 510k
- Root cause
- PMA
- Action
- On 12/12/05, the recalling firm telephoned their sales representatives to inform them of the problem. Letter were hand delivered to the hospitals by the sales representatives.
- Quantity
- 4 units
- Distribution
- Worldwide-The device was shipped to medical facilities in CA, GA, VA. and the UK.
- Lot, serial or model codes
- Serial numbers: 051305-J, 061705-E, 061605-F, and 061705-G.
- 510(k) numbers
- ["K061430"]
- PMA numbers
- not on file
- Product code
- FEB
- 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