AD-TECH Spencer Probe Depth Electrodes recalled for MRI safety labeling error
Ad-Tech Medical Instrument Corporation is recalling 14 units of its AD-TECH Spencer Probe Depth Electrodes due to an incorrect MRI safety label. The devices were labeled as MRI Conditional when they are actually MRI Unsafe, creating a risk of misuse.
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 labeling error on medical electrodes designed for neurological use. While no injuries have been reported, the incorrect MRI safety label creates a risk of serious harm if devices are misused in MRI environments.
Plain-English summary
Ad-Tech Medical Instrument Corporation is recalling 14 units of the AD-TECH Spencer Probe Depth Electrode, model SD08R-AP58X-000 (8-Contact 1.12mm A style). The affected lot numbers are 168788, 855856857, 172999, 873874875R, 174915, and 879880881.
The A-style depth electrodes were labeled with an MRI Conditional symbol, but these devices are not cleared for MRI Conditional use and are actually MRI Unsafe. This labeling discrepancy creates a risk that the electrodes could be incorrectly used in MRI environments, potentially resulting in device malfunction or patient harm.
The affected units were distributed in California and Ohio. Facilities that received these electrodes should verify they are not used in MRI-compatible applications. Contact Ad-Tech Medical Instrument Corporation for instructions on safe handling, replacement, or return of affected devices.
The recalled product
- Product
- AD-TECH Spencer Probe Depth Electrode, REF SD08R-AP58X-000 8-Contact 1.12mm (A style) Depth Electrode
- Manufacturer
- Ad-Tech Medical Instrument Corporation
- Affected units
- 14
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 (4)
- UDI/DI 00841823107688
- Lot Number 168788 855856857
- 172999 873874875R
- 174915 879880881
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.
See all 3 products in this recall →Related recalls
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