FDA recall Z-1105-2021

BEMER INT. AG · Class II · device

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

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

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