ClearanceBrief
Recall Z-0271-05 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic

B & K Medical Systems Inc.

Linear Array Transducer Type: 8809

DateDec 2, 2004 (initiated Nov 12, 2004)
StatusTerminated
ReasonDefect at probe tip may effect sterilization and electrical safety
Root causeOther
ActionBK Medical Wilmington, MA notified accounts by letter dated 11/ 12 /04 via UPS Overnight.. Accounts are requested to return the unit.
Quantity17 units
DistributionCA, CO, CT, FL, LA, GA, NJ, NY, VA, VT
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K000567ULTRASOUND SCANNER TYPE 2102
B & K Medical A/S, Mar 9, 2000
K024236ULTRASOUND SCANNER, TYPE 2400
B-K Medical A/S, Jan 17, 2003
K991937ULTRASOUND SCANNER, MODEL TYPE 2101
B & K Medical A/S, Jul 30, 1999