# FDA recall Z-1105-2021

> **BEMER INT. AG** · Class II · device recall initiated 2021-01-13.

## Product

Bemer-Set/ Pro-Set  for the following models:  REF. 410201 (BEMER Pro-Set), REF. 420201 (B.BOX Professional), REF. 420100 (B.BOX CLASSIC), REF. 410100 (BEMER Classic-Set), REF. 420200 (B.BOX Professional), and REF. 410200  (BEMER Pro - Set)

## Reason for recall

There potential that electromagnetic fields generated in the therapy system may cause technical defects in a patient using an insulin pumps or a malfunction of a pacemaker.

## Distribution

US

## Key facts

- **Recall number:** Z-1105-2021
- **Recalling firm:** BEMER INT. AG
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-01-13
- **Report date:** 2021-02-17
- **Termination date:** 2023-07-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Triesen, N/A, Liechtenstein

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1105-2021

## Citation

> AI Analytics. FDA recall Z-1105-2021. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1105-2021. Source: US FDA. Licensed CC0.

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