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
Check against the official notice below — it lists the full affected range.
OsteoMed, LLC is recalling approximately 533 power consoles and 586 footswitches across multiple product models, including the OsteoPower Power Console 2, D-Power Control Console 2, and Power Control Console 2. The consoles were distributed nationwide in the United States and in multiple countries worldwide, including Argentina, Brazil, Canada, Chile, Colombia, Germany, Italy, Japan, Korea, and others. The devices are being recalled because they do not comply with the latest electrical safety standards IEC 60601, and at least one patient received an electrical shock from an affected console.
The affected consoles and footswitches can be identified by specific product numbers, UDI codes, and serial numbers listed in the recall notice. According to the record provided, no remedy is specified.
Written by software from the official notice below. Not reviewed by a lawyer.
Due to consoles not in compliance with the latest electrical safety standards IEC 60601 and as a result shocked a patient.
Reason for recall: Due to consoles not in compliance with the latest electrical safety standards IEC 60601 and as a result shocked a patient. Distribution: Worldwide distribution - U.S. Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, FL, GA, Guam, HI, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA and WI. The countries of Argentina, Bolivia, Brazil, Canada, Chile, Colombia, Dominican Republic, Ecuador, Germany, Guatemala, Indonesia, Italy, Japan, Korea, Kuwait, Lithu Quantity: 533 consoles and 586 footswitches Lot/code info: 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 0701004 0702021 0701005 0640004 0701006 0701009 0704036 0651097 0714001 0714002 0715029 0715031 0715032 0718003 0719005 0722041 0727024 0727025 0721005 0729044 0734030 0738015 0738017 0740001 0743032 0743033 0743034 0741013 0743036 0743037 0750022 0743038 0750023 0739022 0739023 0803016 0808001 0751032 0811002 0805025 0807056 0820004 0820004 0822030 0832057 0835005 0835004 0839048 0839048 0839049 0839049 0843053 0843054 0852046 0852002 0922072 0931001 0931003 0940011 0944016 0944006 0951020 0949001 101
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.