Recall Z-1105-2021— BEMER INT. AG
Class II · Terminated
Class II FDA medical device recall by BEMER INT. AG, initiated 2021-01-13, terminated 2023-07-12. It names one FDA 510(k) clearance: K151834. 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: 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..
- Recalling firm
- BEMER INT. AG
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-01-13
- Terminated
- 2023-07-12
- Firm location
- Triesen, N/A, Liechtenstein
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.