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U.S. Department of Health and Human Services

Class 2 Device Recall Bemer Classic Set, Bemer ProSet

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  Class 2 Device Recall Bemer Classic Set, Bemer ProSet see related information
Date Initiated by Firm January 13, 2021
Create Date February 10, 2021
Recall Status1 Completed
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 2
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.
510(K) Database 510(K)s with Product Code = NGX and Original Applicant = BEMER Int. AG
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