AD-TECH Spencer Probe Depth Electrode Recalled for MRI Safety Labeling Error
Ad-Tech is recalling Spencer Probe Depth Electrodes due to an incorrect MRI safety label. The device was incorrectly labeled as MR Conditional when it is actually MR Unsafe and not cleared for MRI use.
What this means for you
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: This is an FDA Class II recall involving a labeling error that creates a risk of patient harm. The MRI safety labeling discrepancy could lead to unsafe device use if inadvertently deployed in an MRI setting. No injuries or illnesses have been reported, making this a risk-of-harm situation without documented harm.
Plain-English summary
Ad-Tech Medical Instrument Corporation is recalling the AD-TECH Spencer Probe Depth Electrode (Model SD04R-AP58X-000, 4-Contact 1.12mm A-style). Two units with Lot Number 170052 858859860 were distributed to California and Ohio.
A label discrepancy was identified on the A-style depth electrodes. The device label incorrectly displays the MR Conditional symbol when it should display the MR Unsafe symbol. The A-style contacts are not cleared for MR Conditional use, creating a potential safety risk if the device is inadvertently used in an MRI environment.
Healthcare facilities that received these electrodes should immediately stop use and contact Ad-Tech Medical Instrument Corporation regarding return or replacement options.
The recalled product
- Product
- AD-TECH Spencer Probe Depth Electrode, REF SD04R-AP58X-000 4-Contact 1.12mm (A style) Depth Electrode
- Manufacturer
- Ad-Tech Medical Instrument Corporation
- Hazard
- labeling-error
- mri-safety-miscoding
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 (2)
- UDI/DI 00841823107510
- Lot Number 170052 858859860
Distribution
Distributed nationwide across the United States.
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