FDA Medical Device Recalls (openFDA)
B & K Medical Systems, Inc.: B-K Medical Intraoperative Transducer Type 8814, diagnostic ultrasound transducer, B-K Medical Systems, Inc., Wilmington, MA 01887
- Recall number
- Z-1140-2008
- Recalling firm
- B & K Medical Systems, Inc.
- Product
- B-K Medical Intraoperative Transducer Type 8814, diagnostic ultrasound transducer, B-K Medical Systems, Inc., Wilmington, MA 01887
- Status
- Terminated
- Initiated
- 2008-01-24
- Posted
- 2008-06-10
- Terminated
- 2008-06-23
- Reason
- Crack: Incomplete glue joint in the device housing may affect electrical safety or sterilization.
- Root cause
- Process control
- Action
- B-K Medical issued letter notification on 1/23/08 to accounts via Fed Ex, advising them not to use the unit until a representative can inspect and exchange, if unit is found defective. Instructions are also provided to continue use of the device with a sterile cover until site visit.
- Quantity
- 7
- Distribution
- USA Distribution: MA, MI, PA, TX, and OR.
- Lot, serial or model codes
- Serial Numbers: 1864742, 1869148, 1869619, 1870824, 1870825, 1872061, and 1875317.
- 510(k) numbers
- ["K024236","K043524"]
- PMA numbers
- not on file
- Product code
- IYN
- Firm FEI
- 1000305740
- Firm city
- Wilmington
- 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