Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1105-2021 — 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)

U.S. FDA — Device Enforcement · Liechtenstein · 2021-01-13 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1105-2021
Date of alert
2021-01-13
Country / jurisdiction
Liechtenstein
Risk level
Class II
Risk type
recall
Brand
BEMER INT. AG
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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