Reason: During clinical operation, a malfunction may occur causing a system display freeze with SOMATOM Definition, Definition AS, and definition Edge while running software version syngo CT2012 B and syngo CT2013B.
Distributed: Nationwide Distribution.Reason: Exactech is recalling the InteGrip Acetabular Augments due to an out of range condition for an in-vitro biological evaluation standard.
Distributed: USA Distribution including the states of : FL, VA, NY, OH, ME, TX, CO, and GA.Reason: The internal protection circuitry on the electrosurgical output that prevents a patient from exposure to DC voltage when the device is activated is being compromised during normal use.
Distributed: Nationwide Distribution including CA, MO, PA, NJ, NY, OH, VA, TX, NC, DE, KS, TN, LA, IL, MI, SC, WI, and FL.Reason: Horiba Medical is recalling the ABX PENTRA N Control because it has been updated to include a revised Target Value assignment for Potassium.
Distributed: Worldwide Distribution - USA (nationwide)Reason: The purpose of this correction is to upgrade the Neptune 2 Waste Management Systems in the field to the recently obtained 510(k) clearance specifications.
Distributed: Nationwide and Canada, Germany, Australia, New ZealandReason: The purpose of this correction is to upgrade the Neptune 2 Waste Management Systems in the field to the recently obtained 510(k) clearance specifications.
Distributed: Nationwide and Canada, Germany, Australia, New ZealandReason: Merit Medical Systems, Inc. is voluntarily recalling one lot (B507171) of RAD BOARD RB 100 devices. The affected devices are missing the main label which graphically depicts patient orientation on the board. The issue may allow the board to be oriented in the wrong direction where the semi-radiopaque material in the board (embedded Xenolite) could obscure patient anatomy during fluoroscopy. There
Distributed: Worldwide Distribution - USA including NJ, TX, WV, MN, GA, and Internationally to Mexico and Japan.Reason: Reports of physicians experiencing inability to pass a 0.035" guidewire through the guidewire lumen and exit port at the (proximal) Y-manifold of the imaging catheter.
Distributed: US Nationwide Distribution and MexicoReason: Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
Distributed: Worldwide Distribution-USA (nationwide) and the countries of Argentina, Austria, Brazil, Canada, China, Egypt, France, Germany, Greece, Hong Kong, Italy, Japan, Mexico, Morocco, the Netherlands, Pakistan, South Korea, Spain, Sweden, Switzerland, and the United Kingdom.Reason: Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
Distributed: Worldwide Distribution-USA (nationwide) and the countries of Argentina, Austria, Brazil, Canada, China, Egypt, France, Germany, Greece, Hong Kong, Italy, Japan, Mexico, Morocco, the Netherlands, Pakistan, South Korea, Spain, Sweden, Switzerland, and the United Kingdom.