FHC microTargeting Power Assist System used with the micro… recallZ-0179-06 · FHC, Inc. · initiated Oct 31, 2005
Terminated All recalls posted in November 2005
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from FHC, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Power Assist microTargeting System may advance beyond intended target
FDA root cause category: Other
What the company is doing
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.
Recall details
- Recall number
- Z-0179-06
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Oct 31, 2005
- Posted by the FDA
- Nov 23, 2005
- Recalling firm
- FHC, Inc.
- Quantity
- 70 units
- Product code
- HAW
- FDA submissions
- K011992
- Distribution
- Nationwide Foreign: South Africa, Taiwan, Hong Kong, China, France
Product description
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.
Code information (models, lots, serial numbers)
N/A
Other devices under the same FDA submission
2 devices cleared under K011992 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- microTargeting™ Drive DBS Adapter 66-CN-DB-00453Fhc, Inc. · Neurological stereotaxic Instrument1 recall0 reports
- microTargeting™ Sterile Drape Sleeve 66-DA-SD-00436Fhc, Inc. · Neurological stereotaxic Instrument1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 33946).
- Z-0180-06 · TerminatedMedtronic microTargeting Drive Motor Option used with the micro Targeting Drive System with models: 9033G0711; 9033G0712; 9033G0713; 9033G0811 and FHC 1008-66
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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