FDA Device recall Z-0335-2022
OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 REF 450-0021-00 -OsteoMed D-Power Control Console 2 REF 450-0021-01…
- FDA Device
- Class II
- ongoing
- Published 2021-12-15
On 2021-12-15 the FDA classified a Class II recall of OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 REF 450-0021-00 -OsteoMed D-Power Control Console 2 REF 450-0021-01… by Osteomed, citing due to consoles not in compliance with the latest electrical safety standards IEC 60601 and as a result shocked a patient.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0335-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-10-28 |
| Published | 2021-12-15 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Osteomed |
| Distribution | US |
Product
OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 REF 450-0021-00 -OsteoMed D-Power Control Console 2 REF 450-0021-01 -Power Control Console 2 REF ECOS-450-0021-00 -OsteoMed OsteoPower Power Console 2i REF 450-0005-00 -OsteoMed D-Power Control Console 2i REF 450-0005-01 -Power Control Console 2i REF ECOS-450-0005-00 OsteoMed Footswitches: -OsteoMed BMF Footswitch REF 450-0390 -D-Bi-Directional Master Footswitch REF 450-0380 -D-Uni-Directional Footswitch II REF 450-0350 -D-Bi-Directional Footswitch II REF 450-0360 -D-Uni-Directional Master Footswitch REF 450-0370
Reason
Due to consoles not in compliance with the latest electrical safety standards IEC 60601 and as a result shocked a patient.
Identifiers
| code_info | Product#/Brand Name/UDI Code: 450-0005-00 / OsteoMed OsteoPower Power Console 2i / 0084569401211 450-0021-00 / OsteoMed…Product#/Brand Name/UDI Code: 450-0005-00 / OsteoMed OsteoPower Power Console 2i / 0084569401211 450-0021-00 / OsteoMed OsteoPower Power Console 2 / 0084569401215 450-0390 / OsteoMed BMF Footswitch / 0084569401215 450-0005-01 / OsteoMed D-Power Control Console 2i / 0084569401211 450-0021-01 / OsteoMed D-Power Control Console 2 / 0084569401211 ECOS-450-0021-00 / Power Control Console 2 / 0084569401211 ECOS-450-0005-00 / Power Control Console 2i / 0084569401211 Serial Numbers: 0332004 450-0005-01 0422006 450-0005-00 0423001 450-0005-01 0434003 S 0434004 S 0434010 S 0443004 0423005 450-0005-01 0449004s 0509004S 0509005S 0506027 0445003 0445005 9912003 0515009 0525014 0532001 0521042 0521045 0535006 0535007 0537031 0537032 0537033 0537034 0540005 0547022 0551022 0551025 0552008 0552009 0611004 0604070 0616001 0616002 0615005 0615009 0615010 0615039 0616003 0616005 0615041 0620004 0620005 0622022 0622023 0633024 0641004 0643068 0645002 0645003 0641009 0648023 0648025 0649002 0649003 070 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0335-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.