Recall Z-0179-06 ยท HAW Neurological Stereotaxic Instrument
FHC, Inc.
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.
| Date | Nov 23, 2005 (initiated Oct 31, 2005) |
| Status | Terminated |
| Reason | Power Assist microTargeting System may advance beyond intended target |
| 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 movem |
| Quantity | 70 units |
| Distribution | Nationwide Foreign: South Africa, Taiwan, Hong Kong, China, France |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011992 | FHC MICROTARGETING DRIVE SYSTEM FHC, Inc., Aug 14, 2001 |