Outer box is mislabeled as P/N R2010- Large Radius Loop Electrode instead of P/N R1010- Medium Radius Loop Electrode
Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
UPGRD PRGM 9734638 ADD AxiEM NAVIGATION
Medtronic Navigation
Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.
DRAPE 9732722 TUBE STERILE O-ARM 20PK
Medtronic Navigation
Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.
TUMOR RES. PACK 9733553 AxiEM S.M.
Medtronic Navigation
Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.
A problem can exist in MOSAIQ resulting in the display of incorrect numeric data due to a dose rounding error on printed reports.
The products have a wrong expiration date on their labeling, 5 years instead of 2 years.
Software upgrade to correct potential safety issue related to CyberKnife System that occurs when upgrading the Treatment Delivery Software for the first generation Iris Variable Aperture Collimator.
The MectaLIF Oblique Handle has the laser marking "MEDIAL" on the incorrect side and could result in incorrect insertion of the device during surgery.
Silver Star Brands is recalling the Transport Chair and Rollator in One because they have received several reports of the wheel assembly failing resulting in damaged wheels..
KIT, 9731427, THORACIC TACTILE PROBES
Medtronic Navigation
Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.
The products have a wrong expiration date on their labeling, 5 years instead of 2 years.
When the MC-500 is turned on and coagulation is performed without changing the laser color, the delivery unit occasionally fails to emit the laser, or the power output is lower than the set program.
ENT PRGM 9734636 ADD FUSION NAV AxiEM
Medtronic Navigation
Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.
MOUSE 9732721 STERILE O-ARM 10PK
Medtronic Navigation
Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.
Monteris Medical received a complaint of a separation of the distal sapphire tip from the laser delivery probe.
The products have a wrong expiration date on their labeling, 5 years instead of 2 years.
Monteris Medical received a complaint of a separation of the distal sapphire tip from the laser delivery probe.
SPHERES 8801071 1/TRAY 12PK
Medtronic Navigation
Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.
TRAJ GUIDE KIT, 9733065, BIOPSY, EXT
Medtronic Navigation
Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.
BIT 9733516 2.9mm DRILL STERILE
Medtronic Navigation
Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.