FDA Medical Device Recalls (openFDA)
B & K Medical Systems Inc.: Linear Array Transducer Type: 8809
- Recall number
- Z-0271-05
- Recalling firm
- B & K Medical Systems Inc.
- Product
- Linear Array Transducer Type: 8809
- Status
- Terminated
- Initiated
- 2004-11-12
- Posted
- 2004-12-02
- Terminated
- 2005-01-18
- Reason
- Defect at probe tip may effect sterilization and electrical safety
- Root cause
- Other
- Action
- BK Medical Wilmington, MA notified accounts by letter dated 11/ 12 /04 via UPS Overnight.. Accounts are requested to return the unit.
- Quantity
- 17 units
- Distribution
- CA, CO, CT, FL, LA, GA, NJ, NY, VA, VT
- Lot, serial or model codes
- Serial Numbers: 1831984 1831985 1831986 1831987 1831989 1831990 1831992 1832004 1832007 1844219 1844235 1844239 1844240 1844241 1847871 1847875 1847889
- 510(k) numbers
- ["K024236","K991937","K000567"]
- PMA numbers
- not on file
- Product code
- IYN
- Firm FEI
- 1523841
- Firm city
- North Billerica
- Firm state
- MA
- 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