OsteoMed Surgical Consoles Recalled for Electrical Safety Violations
OsteoMed OsteoPower Power Consoles and footswitches are being recalled due to non-compliance with electrical safety standard IEC 60601. The product has shocked a patient, creating a significant electrical hazard.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II medical device recall with a reported electrical shock injury to a patient. Non-compliance with electrical safety standard IEC 60601 resulted in actual patient harm, meeting the criterion for Severe classification.
Plain-English summary
OsteoMed is recalling specific models of OsteoPower Power Consoles and D-Power Control Consoles, along with associated footswitches. The recalled products include multiple console variants and footswitch models. Approximately 533 consoles and 586 footswitches have been distributed worldwide.
The consoles do not comply with electrical safety standard IEC 60601. Due to this non-compliance, the product has caused a patient to receive an electrical shock, creating a significant electrical hazard to users and operators.
Affected devices have been distributed throughout the United States, Guam, and internationally to countries including Canada, Mexico, United Kingdom, Germany, Spain, Italy, Japan, and others.
Customers and healthcare facilities in possession of these devices should immediately discontinue use and contact OsteoMed, LLC for return or replacement instructions. Users should verify their device model numbers and serial numbers against the official recall notice.
The recalled product
- 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…
- Manufacturer
- Osteomed, LLC
Distribution
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