Osteomed, LLC recalls OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 REF 450-0021-00 -OsteoMed D-Power Control Console 2 REF…
Due to consoles not in compliance with the latest electrical safety standards IEC 60601 and as a result shocked a patient.
Read the official notice →- Date
- 2021-12-15
- Country
- United States
- Brand
- Osteomed
- Product
- OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 REF 450-0021-00 -OsteoMed D-Power Control Console 2 REF…
- Classification
- Class II
- Units
- Worldwide distribution - U.S. Nationwide distribution in the states of AL, AR,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Osteomed recalls
- 2023-07-19
USOsteomed, LLC recalls REF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only, Sterile
Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole.
FDA · DeviceOsteomed, LLCWorldwide - US Nationwide distribution in the states of AZ, CA, FL, GA, KS,…Official notice →
Other drugs & medical recalls in the United States
- 2021-12-15
- US
Philips North America Llc recalls BV Endura with Software Release 2.3- A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718075
Instructions for Use do not specify the maximum surface temperature of the X-ray tank (assembly housing the X-ray tube, beam filter & cooling oil) and the image intensifier/detector of the system as required an result…
FDA · DevicePhilips North America LlcWorldwide distribution - US Nationwide and the countries of Afghanistan,…Official notice → - US
Argon Medical Devices, Inc recalls SuperCore Biopsy Instrument: REF/Product Description: 701114090/SUPERCORE BIOPSY INSTR 14GA X 9CM; 701114150/SUPERCORE BIOPSY INSTR…
Due to component (housing and plunger) detaching from the semi-automatic biopsy instruments.
FDA · DeviceArgon Medical Devices, IncWorldwide distribution - U.S. Nationwide distribution in the states of AK, AL,…Official notice → - US
Covidien Llc recalls Puritan Bennett 980 Series Ventilator, 980X2ESDIEC
Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
- US
Orchestrate Orthodontic Technologies, Inc. recalls O3D ORCHESTRATE Orthodontic Technologies User Manual and Data Processing Instructions (model preparation for tooth…
Due to product label/labeling being altered from it's approved state.
FDA · DeviceOrchestrate Orthodontic Technologies, Inc.Worldwide distribution - U.S. Nationwide distribution in the states of AL, AR,…Official notice → - US
Northgate Technologies, Inc. recalls Boston Scientific AUTOLITH TOUCH Bipolar Electrohydraulic Lithotripter, REF M005466800. The device is designed to be used with…
The languages for Russian, Romanian, Slovak, and Czech have the power settings for high and low switched in the device.
- US
Covidien Llc recalls Covidien Sonicision Battery Charger-intended to charge the Sonicision Reusable Battery Pack and to provide information on the battery…
Intermittent risk of electric shock to users if an affected charger is used in conjunction with a faulty or bypassed institutions Mains Protective Earth (Ground) circuit