Osteomed recalls OsteoPower Power Console 2 and 2i models due to electrical safety compliance issues with IEC 60601 standards, which may have caused patient shocks. Affected units include specific model numbers and serial numbers listed in the recall notice.
Due to consoles not in compliance with the latest electrical safety standards IEC 60601 and as a result shocked a patient.
Osteomed is recalling several models of OsteoPower Power Consoles and footswitches because they don't meet the latest electrical safety standards (IEC 60601), which could have caused patient shocks. This is a safety issue that requires immediate attention.
The consoles and footswitches were not in compliance with the latest electrical safety standards (IEC 60601), which means they could have caused electrical shocks to patients during medical procedures.
Healthcare professionals using Osteomed OsteoPower Power Consoles or footswitches for medical treatments are most at risk. Patients using these devices could be exposed to electrical shocks.
Check if your device has the model numbers listed: OsteoPower Power Console 2 (REF 450-0021-00), OsteoPower Power Console 2i (REF 450-0005-00), D-Power Control Console 2 (REF 450-0021-01), or D-Power Control Console 2i (REF 450-0005-01). Also, verify the serial numbers provided in the recall notice.
Look for the model number on your device: OsteoPower Power Console 2 (REF 450-0021-00), OsteoPower Power Console 2i (REF 450-0005-00), D-Power Control Console 2 (REF 450-0021-01), or D-Power Control Console 2i (REF 450-0005-01).
Check if your device's serial number matches any listed in the recall notice (e.g., 0422006, 450-0005-00, etc.).
The recall includes OsteoPower Power Console 2 (REF 450-0021-00), OsteoPower Power Console 2i (REF 450-0005-00), D-Power Control Console 2 (REF 450-0021-01), D-Power Control Console 2i (REF 450-0005-01), and specific footswitch models with corresponding serial numbers.
Check your device's model number and serial number against the list provided in the recall notice. Affected units have specific model references and serial numbers listed in the document.
The recall does not specify a remedy, so affected users should contact Osteomed directly for guidance on next steps.
We’ve drafted a message you can send Osteomed to request your refund or repair — edit it as you like.
Subject: Recall Z-0335-2022 — Osteomed Osteomed Hello, I own a Osteomed that is covered by recall Z-0335-2022 from Osteomed. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
