Disposable Subdermal Needle Electrode, Pt/lr, 12 x 0.40mm, product number TE/S46/638, 25 needles per package, sterile.
Reported: September 21, 2022 Initiated: August 9, 2022 #Z-1737-2022
Product Description
Disposable Subdermal Needle Electrode, Pt/lr, 12 x 0.40mm, product number TE/S46/638, 25 needles per package, sterile.
Reason for Recall
Burns of varying degrees can occur to patients with electrodes left in while in the MRI scanner as a result of inadequate safety information in the IFU.
Details
- Recalling Firm
- Technomed Europe
- Units Affected
- 37/25-electrode boxes
- Distribution
- US Nationwide distribution in the states of CA, FL, NH, OH, and WA.
- Location
- Maastricht-Airport
Frequently Asked Questions
What product was recalled? ▼
Disposable Subdermal Needle Electrode, Pt/lr, 12 x 0.40mm, product number TE/S46/638, 25 needles per package, sterile.. Recalled by Technomed Europe. Units affected: 37/25-electrode boxes.
Why was this product recalled? ▼
Burns of varying degrees can occur to patients with electrodes left in while in the MRI scanner as a result of inadequate safety information in the IFU.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 21, 2022. Severity: Moderate. Recall number: Z-1737-2022.
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