Recall Z-1105-2021 ยท NGX Stimulator, Muscle, Powered, For Muscle Conditioning
BEMER INT. AG
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)
| Date | Jan 13, 2021 |
| Status | Terminated |
| 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. |
| Root cause | Labeling Change Control |
| Action | On January 13, 2021, Bemer USA sent a "Urgent Safety Information" letter to affected consignees via E-Mail. In addition to informing consignees about the recall the firm asked consignees to take the following actions: 1. Patients who wear an active medical implant that leads to stimulation (e.g., pacemakers, defibrillators, brain stimulators, muscle stimulators) should not use the BEMER therapy system unless a specialist physician carries out a personal risk assessment and subsequently expressly tells the patient that he/she can continue the treatment. If you are an affected patient, please |
| Quantity | 197,724 units |
| Distribution | US |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151834 | BEMER Classic Set, BEMER Pro-Set Bemer Int AG, Feb 22, 2017 |