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BEMER INT. AG recalls Bemer-Set/ Pro-Set for the following models: REF. 410201 (BEMER Pro-Set), REF. 420201 (B.BOX Professional), REF. 42010
Recalled February 17, 2021 · FDA recall Z-1105-2021 · BEMER INT. AG
Hazard
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. · FDA Class II
Units
197,724 units
Sold at
US
Description
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.
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)
Manufacturer(s)
BEMER INT. AG
Made in
Liechtenstein
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →