2.5 mm Guide Rod w/Smooth Tip 950 mm, Sterile
Synthes (USA) Products
Class I - Dangerous
The peel pouches for the affected reaming rods and extraction hooks are delaminating.
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Other Medical Devices
🏥 Medical Devices • 15,809 recalls
Pathfast D-Dimer, Reference number: PF1051-KUS
Lsi Medience
Class I - Dangerous
Two complaints were received about decrease in sensitivity (control value and/or calibration value) of the product.
Manifold Kit. Catalog Number K09-11867AP
Merit Medical Systems
Class I - Dangerous
Merit Medical Systems, Inc. announces a voluntary field action for various Merit Medical Procedure Kits due to a compromised sterile barrier.
Procedure Kit. Catalog Numbers K12-04830B and K12-YP030A
Merit Medical Systems
Class I - Dangerous
Merit Medical Systems, Inc. announces a voluntary field action for various Merit Medical Procedure Kits due to a compromised sterile barrier.
2.5 mm Reaming Rod W/Ball Tip 650 mm, Sterile
Synthes (USA) Products
Class I - Dangerous
The peel pouches for the affected reaming rods and extraction hooks are delaminating.
Waste Management Kit. Catalog Number K10-04381AP
Merit Medical Systems
Class I - Dangerous
Merit Medical Systems, Inc. announces a voluntary field action for various Merit Medical Procedure Kits due to a compromised sterile barrier.
The Hemotherm 400CE 115v, containing power board p/n 39945
Cincinnati Sub-Zero Products
Class I - Dangerous
The device may not maintain water flow or temperature control.
Philips Healthcare System X-ray Tomography Computed :
Philips Electronics North America
Class I - Dangerous
It was discovered the patient support tabletop may fail to move in the horizontal direction when it is commanded to do so during CT scans due to a potential mechanical linkage failure.
Class I - Dangerous
Breach in sterile barrier compromising product sterility
Product was found to contain excess residual levels of hydrogen peroxide.
Fluid Management Set. Catalog Number K08-MP5159A
Merit Medical Systems
Class I - Dangerous
Merit Medical Systems, Inc. announces a voluntary field action for various Merit Medical Procedure Kits due to a compromised sterile barrier.
Aquilion Prime TSX-303A Aquilion PRIME is a multislice helical CT system with an 40-row detector. High-speed rotation allows rapid data acquisition and shortens scan times, while the fast reconstruction unit further improves throughput, reducing the time required for diagnosis.
Toshiba American Medical Systems
Class I - Dangerous
Toshiba American Medical Systems (TAMS) is recalling the Aquilion CT system because it has been reported that the cooling oil in the x-ray tube heat exchanger may leak during system operation.
2.5 mm Reaming Rod with Ball Tip & Extension/950 mm, Sterile
Synthes (USA) Products
Class I - Dangerous
The peel pouches for the affected reaming rods and extraction hooks are delaminating.
2.5 mm TI Calibrated Reaming Rod 850 mm, Sterile
Synthes (USA) Products
Class I - Dangerous
The peel pouches for the affected reaming rods and extraction hooks are delaminating.
3.0 mm Reaming Rod/950 mm w/straight Ball Tip, Sterile
Synthes (USA) Products
Class I - Dangerous
The peel pouches for the affected reaming rods and extraction hooks are delaminating.
Custom Fluid Management Set, Sterile, EO, Rx Only Used to transfer contrast media and saline from a container to a patients vascular system.
Merit Medical Systems
Class I - Dangerous
Merit Medical Systems, Inc. announces a voluntary field action for Fluid Administration Sets due to a molding defect in the drip chamber.
Totalis, RIGID and Totalis"I Flex ENDO KIT, Manufacturer: C.R. Bard, Inc., Covington, GA 30014.
C.R. Bard
Class I - Dangerous
Labeling: Statement was added to the Warnings/Precautions section requesting end users to consider the presence of a knot if significant resistance is encountered during attempts at removal.
Class I - Dangerous
Siemens is releasing a software update that provides bug-fixes to improve system performance for customers with SOMATOM Definition AS, SOMATOM Definition Edge, SOMATOM Definition Flash Systems with software version VA48A_SP2 and Care Contrast license correction of potential safety issues.
Class I - Dangerous
Siemens is releasing a software update that provides bug-fixes to improve system performance for customers with SOMATOM Definition AS, SOMATOM Definition Edge, SOMATOM Definition Flash Systems with software version VA48A_SP2 and Care Contrast license correction of potential safety issues.
iConnect Access software. The firm name on the label is Merge Healthcare, Hartland, WI.
Merge Healthcare
Class I - Dangerous
Software displayed incorrect prior reports in the viewport area, only when more than one prior study (2 or more) was viewed.