Z-1105-2021Class II

Bemer-Set/ Pro-Set for the following models: REF. 410201 (BEMER Pro-Set), REF. 420201 (B.BOX Professional)...

Name: Z-1105-2021 Bemer-Set/ Pro-Set for the following models: REF. 410201 (BEMER Pro-Set), REF. 420201 (B.BOX Professional)...
Creator: Bemer Int. Ag
Published: 2021-01-13
License: https://open.fda.gov/license/

BEMER Int. AG / initiated 2021-01-13 / Terminated / root cause: labeling and UDI

FDA source

BEMER INT. AG began a recall of 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... on 2021-01-13. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1105-2021
Classification: Class II
Status: Terminated
Initiated: 2021-01-13
Posted: 2021-02-10
Terminated: 2023-07-12
Recalling firm: BEMER Int. AG
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)
Product code: NGX Stimulator, Muscle, Powered, For Muscle Conditioning
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.
Root cause tag: labeling and UDI
FDA 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 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
Product codes and lots: All Lot Numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1105-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1105-2021	Class II	Terminated	Voluntary: Firm initiated	2021-02-17	2021-02-10

Product code NGX

K151834Class IIBEMER Classic Set, BEMER Pro-SetBemer Int AG / cleared 2017-02-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)