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U.S. Department of Health and Human Services

Class 2 Device Recall FC400SP microTargeting StimPilot Single Procedure Kit

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 Class 2 Device Recall FC400SP microTargeting StimPilot Single Procedure Kitsee related information
Date Initiated by FirmOctober 20, 2008
Date PostedDecember 18, 2008
Recall Status1 Terminated 3 on May 02, 2012
Recall NumberZ-0499-2009
Recall Event ID 50103
510(K)NumberK991522 
Product Classification Electrode - Product Code GZL
ProductFC400SP 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.
Code Information Serial numbers: 01689 through 01708 and 01756 through 01758.
Recalling Firm/
Manufacturer		 FHC, Inc.
1201 Main Street
Bowdoinham ME 04008
For Additional Information ContactSAME
207-666-8190
Manufacturer Reason
for Recall		Mislabeled: May contain an electrode longer than labeled size
FDA Determined
Cause 2		Pending
ActionFHC 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.
Quantity in Commerce23 kits (46 electrodes-2 electrodes/kit)
DistributionNationwide Distribution --- including states of CA, CO, FL, LA, NM, PA, TN, and PR.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = GZL
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