Z-0179-06

FHC microTargeting Power Assist System used with the micro Targeting Drive System, models: 66-DA-ME; 66EL-MC...

Name: Z-0179-06 FHC microTargeting Power Assist System used with the micro Targeting Drive System, models: 66-DA-ME; 66EL-MC...
Creator: FHC, Inc.
Published: 2005-10-31
License: https://open.fda.gov/license/

FHC, Inc. / initiated 2005-10-31 / Terminated

FDA source

FHC, Inc. began a recall of FHC microTargeting Power Assist System used with the micro Targeting Drive System, models: 66-DA-ME; 66EL-MC; 66EL-MS;66EL-MS-02; 66-EL-MS-03; 66-EL-RM... on 2005-10-31. The reason FDA records is "Power Assist microTargeting System may advance beyond intended target". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0179-06
Status: Terminated
Initiated: 2005-10-31
Posted: 2005-11-23
Terminated: 2006-06-07
Recalling firm: FHC, Inc.
Product: FHC microTargeting Power Assist System used with the micro Targeting Drive System, models: 66-DA-ME; 66EL-MC; 66EL-MS;66EL-MS-02; 66-EL-MS-03; 66-EL-RM; MT-DS-AM; MT-DS-MD.
Product code: HAW Neurological Stereotaxic Instrument
Reason for recall: Power Assist microTargeting System may advance beyond intended target
FDA root cause: 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: 70 units
Distribution: Nationwide Foreign: South Africa, Taiwan, Hong Kong, China, France
Product codes and lots: N/A

Product code HAW

K011992Class IIFhc Microtargeting Drive SystemFHC, Inc. / cleared 2001-08-14

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About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)