BEMER INT. AG Recall 87094
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)
BEMER INT. AG Recall 87094 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1105-2021 |
| Event ID | 87094 |
| Event 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) |
| Product Type | Devices |
| Distribution | US |
| Quantity | 197,724 units |
| Recall 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. |
| Device Classification | 20210217 |
| Device Code Info | All Lot Numbers |
| Center Classification Date | 20210210 |
| Recall Initiation Date | 20210113 |
| Recalling Firm | BEMER INT. AG |
| Initial Notification | Letter |
| Similar To |