U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Power assist microtargeting system may advance beyond intended target.
조치
FHC Inc. and Medtronic notified customers by letter and instructs the customer to return their Motor Option for upgrade to include the following components:
1) Handheld Remote Control, 2) Motor Controller Unit with Display, 3) Motor, and 4)
Medical Power Adapter. (See pictures at the end of this communication). Until the Motor Option has been updated, instructions to customers are:
Prior to each clinical use:
¿ Ensure the microTargeting Drive system is calibrated before each clinical use per the User Guide.
¿ Check the microTargeting Drive system functionality over a range of at least 10mm movement.
¿ Should any performance indicating either a stall or unintended movement be observed, immediately unplug the 12V Medical Power Adapter, remove the
MicroTargeting Drive Motor Option from the system, and continue using the microTargeting Drive in the manual mode.
During clinical use:
¿ Should any performance indicating either a stall or unintended movement be observed, immediately unplug the 12V Medical Power Adapter, remove the
MicroTargeting Drive Motor Option from the system, and continue using the microTargeting Drive in the manual mode.
Every 100 uses or annually:
¿ Have your microTargeting Drive system checked by the manufacturer per the User Guide.
¿ Have your equipment support department check or tighten the MicroTargeting Drive Motor Option Remote Control Knob set screws, tighten as needed, and then re-calibrate.
Nationwide Foreign: South Africa, Taiwan, Hong Kong, China, France
제품 설명
Medtronic microTargeting Drive Motor Option used with the micro Targeting Drive System with models: 9033G0711; 9033G0712; 9033G0713; 9033G0811 and FHC 1008-66