FC400SP microTargeting StimPilot Single Procedure Kit Distributed by Medtronic Inc., Minneapolis, MN Ref: FHC4000SP Intended for use in intra-operative recording of single unit neuronal activity or intra-operative stimulation of neural elements in the brain.
FDA Recall Z-0499-2009 · Posted 2008-12-18
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Recalling FirmFHC, Inc.
Recall StatusTerminated
Product CodeGZL
Date Initiated2008-10-20
Date Terminated2012-05-02
Product Quantity23 kits (46 electrodes-2 electrodes/kit)
Reason for Recall
Mislabeled: May contain an electrode longer than labeled size
Firm Action
FHC notified customers via an Urgent: Medical Device Recall letter dated 10/20/08 advising users to remove the recalled electrodes from inventory and set the product aside for inspection by your FHC representative. Customers were asked to document their actions by completing the enclosed form and faxing it back to FHC at 207-666-8539.
Root Cause
Pending
Distribution Pattern
Nationwide Distribution --- including states of CA, CO, FL, LA, NM, PA, TN, and PR.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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