Class 2 Device Recall Bemer Classic Set, Bemer ProSet

• Date Initiated by Firm: January 13, 2021
• Create Date: February 10, 2021
• Recall Status: Terminated on July 12, 2023
• Recall Number: Z-1105-2021
• Recall Event ID: 87094
• 510(K)Number: K151834
• Product Classification: Stimulator, muscle, powered, for muscle conditioning - Product Code NGX
• 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)
• Code Information: All Lot Numbers
• Recalling Firm/ Manufacturer: BEMER INT. AG; Austrasse 15; Triesen Liechtenstein
• For Additional Information Contact: Mr. John Rockenstein; 1800-554-9117
• Manufacturer 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.
• FDA Determined 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 stop using the BEMER therapy system immediately and consult your specialist physician. The specialist physician will then decide whether or not you can continue using the BEMER therapy system. 2. In the risk assessment, your specialist physician must estimate whether or not the BEMER therapy can cause possible interference at a maximum flow density of 150 ¿T (average flow density for total body treatment 21 ¿T), based on the individually set threshold values of the implant and under consideration of the distance between the applicator (coil) and the pacemaker with its electrodes. If the specialist physician estimates that interference and therefore, operating safety, cannot be excluded, do not continue the BEMER therapy system treatment. 3. Patients wearing active medical implants designed to deliver medication (e.g., medication pumps) have an absolute contraindication. In other words, they may no longer use the BEMER therapy system. These contraindications must be observed by the user for future use. 4. If you have re-sold the aforementioned products in new condition to a third party, you are required to forward a copy of this notice to all your customers, including all professional users (doctors, therapists, hospitals, etc.). Alternatively, please inform the contact person listed below so we can ensure the compliance with this notice requirement. Your applicabl
• Quantity in Commerce: 197,724 units
• Distribution: US
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = NGX and Original Applicant = BEMER Int. AG