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)
Z-1105-2021
Product summary
- Firm
- BEMER INT. AG
- Event
- Event 87094
- Status
- Terminated
- Classification
- Class II
- Quantity
- 197,724 units
- Official record key
device-enforcement:Z-1105-2021
Official wording
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.
Code information: All Lot Numbers
Distribution pattern: US
Derived failure modes
-
Unknown
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.