B-K Medical Intraoperative Transducer Type 8814, diagnostic ultrasound transducer, B-K Medical Systems, Inc., Wilmington
FDA device recall Z-1140-2008 · posted 2008-06-10 · Terminated
Recall details
- Recalling firm
- B & K Medical Systems, Inc.
- Reason for recall
- Crack: Incomplete glue joint in the device housing may affect electrical safety or sterilization.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- IYN
- Quantity affected
- 7
- Distribution
- USA Distribution: MA, MI, PA, TX, and OR.
- Date initiated
- 2008-01-24
- Date posted
- 2008-06-10
- Date terminated
- 2008-06-23
- Location
- Wilmington, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ULTRASOUND SCANNER PRO FOCUS, MODEL 2202 (K043524) | B-K Medical A/S | 2005-01-13 |
| ULTRASOUND SCANNER, TYPE 2400 (K024236) | B-K Medical A/S | 2003-01-17 |