Home / Recalls / BEMER INT. AG / Z-1105-2021

Z-1105-2021 Class II Terminated

Recalled by BEMER INT. AG — Triesen, N/A

Recall Details

Product Type
Devices
Report Date
February 17, 2021
Initiation Date
January 13, 2021
Termination Date
July 12, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
197,724 units

Product Description

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 Pattern

US

Code Information

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