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U.S. Department of Health and Human Services

Class 2 Device Recall ADTECH Spencer

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 Class 2 Device Recall ADTECH Spencersee related information
Date Initiated by FirmSeptember 19, 2024
Date PostedOctober 24, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0220-2025
Recall Event ID 95414
510(K)NumberK163355 
Product Classification Electrode, depth - Product Code GZL
ProductAD-TECH Spencer Probe Depth Electrode, REF SD06R-AP58X-000 6-Contact 1.12mm (A style) Depth Electrode
Code Information UDI/DI 00841823107589, Lot Number 169260 858859860, 169258 858859860
Recalling Firm/
Manufacturer		 Ad-Tech Medical Instrument Corporation
400 W Oakview Pkwy
Oak Creek WI 53154-7213
For Additional Information ContactFrederick Guesneau
262-634-1555 Ext. 3000
Manufacturer Reason
for Recall		Ad-Tech is recalling these A-Style SD Depth Electrodes because a label discrepancy was identified on A style contact SD electrodes where the MR Conditional symbol was incorrectly placed instead of the MR Unsafe symbol. The A style contacts were not cleared for MR Conditional use. Our records indicate you have received one or more of the affected lots listed above.
FDA Determined
Cause 2		Employee error
ActionAD-TECH issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 09/19/2024. The notice explained the problem with the devices, risk to health, and requested the consignee contact customer support to obtain an RMA to expedite the return of the affected product. For questions: contact your Ad-Tech Clinical Specialist.
Quantity in Commerce4 units
DistributionUS Nationwide distribution in the states of CA, OH.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = GZL
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