Z-1105-2021 Class II Terminated
FDA device recall Z-1105-2021 was initiated by BEMER INT. AG on January 13, 2021 and is designated Class II. 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. The recall status is terminated (terminated July 12, 2023). Affected quantity: 197,724 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 17, 2021
- Initiation Date
- January 13, 2021
- Termination Date
- July 12, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 197,724 units
Product 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)
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.
Distribution Pattern
US
Code Information
All Lot Numbers