# FDA recall Z-1737-2022

> **Technomed Europe** · Class II · device recall initiated 2022-08-09.

## Product

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

US Nationwide distribution in the states of CA, FL, NH, OH, and WA.

## Key facts

- **Recall number:** Z-1737-2022
- **Recalling firm:** Technomed Europe
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-08-09
- **Report date:** 2022-09-21
- **Termination date:** 2024-04-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Maastricht-Airport, Netherlands

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1737-2022

## Citation

> AI Analytics. FDA recall Z-1737-2022. Retrieved 2026-07-18 from https://api.ai-analytics.org/recall/Z-1737-2022. Source: US FDA. Licensed CC0.

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