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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic

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  Class 2 Device Recall Medtronic see related information
Date Initiated by Firm October 31, 2005
Date Posted November 23, 2005
Recall Status1 Terminated 3 on June 07, 2006
Recall Number Z-0180-06
Recall Event ID 33946
510(K)Number K011992  
Product Classification Neurological Stereotaxic Instrument - Product Code HAW
Product Medtronic microTargeting Drive Motor Option used with the micro Targeting Drive System with models: 9033G0711; 9033G0712; 9033G0713; 9033G0811 and FHC 1008-66
Code Information N/A
Recalling Firm/
Manufacturer		 FHC, Inc.
9 Main St
Bowdoinham ME 04008-4418
For Additional Information Contact Keri Seitz
207-666-5651
Manufacturer Reason
for Recall		 Power Assist microTargeting System may advance beyond intended target
FDA Determined
Cause 2		 Other
Action 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.
Quantity in Commerce 230 units
Distribution Nationwide Foreign: South Africa, Taiwan, Hong Kong, China, France
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HAW and Original Applicant = FHC, INC.
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