System Correction: IMPRIS Imaging Inc Issues Correction for IMRIS Neuro III-SV
IMPRIS corrects IMRIS Neuro III-SV models due to the potential of ice blockage in the helium venting pipe
FDA MedWatch
MRI System Correction: Siemens Healthineers Issues Correction for 3 Tesla MRI Systems
Siemens Healthineers is correcting 3 Tesla MRI systems including MAGNETOM and BioGraph mMR due to the potential for ice blockage in the magnet venting system
Early Alert: Convenience Kit Needle Issue from Integra LifeSciences
Integra LifeSciences is removing certain lots of Microsensor and Cerelink ICP Kits with potential corrosion stains on the included Tuohy Needle.
Infusion Pump Correction: Baxter Issues Correction for Novum IQ Large Volume Pumps
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program
Handelnine Global Limited d/b/a as Navafresh Issues Nationwide Recall of Rheumacare Capsules by Virgo UAP Pharma Pvt. Ltd. (Virgo), Due to Elevated Lead Levels
Handelnine Global Limited d/b/a Navafresh is voluntarily recalling Lot Numbers CAM040 & CALO79-N of Rheumacare Capsules by Virgo UAP Pharma Pvt. Ltd. (Virgo) to the consumer level. In test conducted by the Food and Drug Administration the product has been found to contain lead at levels up to 11,100
Microbore Extension Set Recall: B. Braun Medical Inc. Removes Microbore Extension Sets
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program
Cardiac Cannula Recall: Medtronic Removes DLP Left Heart Vent Catheter
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program
Blood Pump Controller Correction: Abiomed Updates Use Instructions for Automated Impella Controllers
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program