AD-TECH Spencer Probe Depth Electrode recalled for MRI safety label discrepancy
Ad-Tech is recalling A-style depth electrodes due to incorrect MRI safety labeling. Devices were labeled as MR Conditional when they should be labeled MR Unsafe.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with a safety-critical labeling error regarding MRI compatibility. No injuries or illnesses have been reported, but incorrect labeling could lead to improper device use in MRI environments.
Plain-English summary
Ad-Tech Medical Instrument Corporation is recalling the AD-TECH Spencer Probe Depth Electrode (Model SD06R-AP58X-000, 6-Contact, 1.12mm A-style) due to a label discrepancy. The affected devices were labeled with an incorrect MR Conditional symbol instead of the MR Unsafe symbol. The A-style contacts in these devices have not been cleared for MRI Conditional use and are not safe for use in MRI environments without proper verification.
The recall affects 4 units distributed nationwide in California and Ohio. The affected lot numbers are 169260 and 169258 (UDI/DI 00841823107589).
Healthcare providers who use these devices should stop using the affected units immediately and contact Ad-Tech Medical Instrument Corporation. Do not use these electrodes in MRI environments without verifying the actual MRI safety status of your specific device with the manufacturer.
The recalled product
- Product
- AD-TECH Spencer Probe Depth Electrode, REF SD06R-AP58X-000 6-Contact 1.12mm (A style) Depth Electrode
- Manufacturer
- Ad-Tech Medical Instrument Corporation
- Hazard
- Affected units
- 4
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- UDI/DI 00841823107589
- Lot Number 169260 858859860
- 169258 858859860
Distribution
Part of a larger recall action
This product is one of 3 recalled by Ad-Tech Medical Instrument Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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