AD-TECH Spencer Probe Depth Electrode, REF SD08R-AP58X-000 8-Contact 1.12mm (A style) Depth Electrode
Summary
The FDA issued a Class II for AD-TECH Spencer Probe Depth Electrode, REF SD08R-AP58X-000 8-Contact 1.12mm (A s by Ad-Tech Medical Instrument Corporation. Reason: 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 Condit.
Details
Source
Device Recall
External ID
Z-0221-2025
Action Date
2024-10-30
Status
Completed
Category
device
Product Description
AD-TECH Spencer Probe Depth Electrode, REF SD08R-AP58X-000 8-Contact 1.12mm (A style) Depth Electrode
Lot/Code Info: UDI/DI 00841823107688, Lot Number 168788 855856857, 172999 873874875R, 174915 879880881
Quantity Affected: 14 units
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.
Distribution
US Nationwide distribution in the states of CA, OH.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-09-19
Company
Oak Creek, WI
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 253 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Ad-Tech Medical Instrument Corporation has 8 FDA actions in our database, including 6 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Ad-Tech Medical Instrument Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Ad-Tech Medical Instrument Corporation have FDA actions?
Ad-Tech Medical Instrument Corporation has 8 FDA actions in our database, including 6 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0221-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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