Z-1737-2022 Class II Terminated
FDA device recall Z-1737-2022 was initiated by Technomed Europe on Aug 9, 2022 and is designated Class II. 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. The recall status is terminated (terminated Apr 11, 2024). Affected quantity: 37/25-electrode boxes.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 21, 2022
- Initiation Date
- Aug 9, 2022
- Termination Date
- Apr 11, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 37/25-electrode boxes
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.
Distribution Pattern
US Nationwide distribution in the states of CA, FL, NH, OH, and WA.
Code Information
Lot numbers 044220, exp. 1/1/2023; 045077, exp. 3/1/2023; 045443, exp. 4/1/2023; and 049285, exp. 7/1/2024; UDI-DI 08718375861530.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1737-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026