Linear Array Transducer Type: 8809
FDA device recall Z-0271-05 · posted 2004-12-02 · Terminated
Recall details
- Recalling firm
- B & K Medical Systems Inc.
- Reason for recall
- Defect at probe tip may effect sterilization and electrical safety
- Action taken
- BK Medical Wilmington, MA notified accounts by letter dated 11/ 12 /04 via UPS Overnight.. Accounts are requested to return the unit.
- Root cause
- Other
- Status
- Terminated
- Product code
- IYN
- Quantity affected
- 17 units
- Distribution
- CA, CO, CT, FL, LA, GA, NJ, NY, VA, VT
- Date initiated
- 2004-11-12
- Date posted
- 2004-12-02
- Date terminated
- 2005-01-18
- Location
- North Billerica, 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, TYPE 2400 (K024236) | B-K Medical A/S | 2003-01-17 |
| ULTRASOUND SCANNER TYPE 2102 (K000567) | B & K Medical A/S | 2000-03-09 |
| ULTRASOUND SCANNER, MODEL TYPE 2101 (K991937) | B & K Medical A/S | 1999-07-30 |