Class I - Dangerous
Inability for the guidewire to pass through the needles included with the catheter kits.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
EVA Floor Lifts, Model Numbers: 400, 450, 600
Handicare AB
Class I - Dangerous
After feedback from customers and internal suspicion, Handicare has become aware that abnormal use of Eva-lifts could lead to a deterioation in the joint of the liftarm. This could lead to injury if the joint breaks. All lifts must therefore be checked and reported back to the manuafacturer.
Rapid2 PSU Stim Interconnecting Cable - Product Usage: indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.
The Magstim Company Limited
Class I - Dangerous
It was identified that there is a potential for the Stim Interconnecting high Voltage Cable located at the rear of the Rapid2 and Horizon power supply unit to fail.
Class I - Dangerous
Failure to prime due to an assembly error
Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2ÂŋC. Failure to correctly measure patient body temperatures could lead to an incorrect diagnosis and insufficient treatment
Class I - Dangerous
Inability for the guidewire to pass through the needles included with the catheter kits.
Class I - Dangerous
Inability for the guidewire to pass through the needles included with the catheter kits.
Siemens Cios Spin VA30-mobile X-Ray system, Material # 10308194 - Product Usage: The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications.
Siemens Medical Solutions USA
Class I - Dangerous
Main cable can be plugged or unplugged from the X10 connector which is part of the main unit (c-arm) at any time during clinical session. If the system displays the error message Err 16305 / 80, the unplugging of the main cable can cause an unsafe electrical voltage (125 V DC) at the X10 connector and result in an electrical shock if the user or other persons touch the contact pins of the X10 connector. These contact pins are accessible when the main cable is unplugged from the X10 connector
Stryker Power-PRO TL cot-powered ambulance cot Model Number 6550 - Product Usage: is a powered wheeled stretcher that is intended to support and transport the entire body of a traumatized, ambulatory or non-ambulatory human patient (includes infants and adults).
Stryker Medical Division of Stryker
Class I - Dangerous
Ambulance Cots may not meet crash test standard BS EN 1789
Class I - Dangerous
Inability for the guidewire to pass through the needles included with the catheter kits.
Class I - Dangerous
Potential for out of range microbial results
iQ200 Series Urine Microscopy Analyzer- All part numbers
Beckman Coulter
Class I - Dangerous
A defect in the SATA power adapter cable within the instrument s computer has the potential risk for an electrical short that may lead to the following outcomes: charring and/or melting of the SATA adapter cable within the computer s metal enclosure, smoke emanating from PC6, flames contained within PC6, or an inability to use the device s CD-ROM.
Class I - Dangerous
Failure to prime due to an assembly error
Class I - Dangerous
Failure to prime due to an assembly error
Gore DrySeal Flex Introducer Sheath, Catalog #DSF1433, 33cm 14FR, Sterile. The responsible firm on the label is W. L. Gore & Associates, Inc., Flagstaff, AZ.
W. L. Gore & Associates
Class I - Dangerous
The devices were mislabeled with the incorrect product size resulting in 16Fr devices being labeled as 14Fr devices.
Saline Flush Syringe compromised sterility due to holes in the packaging.
Saline Flush Syringe compromised sterility due to holes in the packaging.
Class I - Dangerous
Arterial Line Kits include thicker curved reverse-cutting needle with a 0-silk suture, instead of the usual straight-cutting needle with a 3-0 silk suture. The thicker suture may be more difficult to tie. The curved needle requires the use of a needle driver, there is a risk of needle stick to the surgeon tries to do it with fingers instead.
Class I - Dangerous
The FlexLab Centrifuge Module loading algorithm may lead to unbalanced loads which could damage the centrifuge.
Class I - Dangerous
The firm has received reports of tip separation during usage of the catheters, which may expose patients to unintended dislodgement of the tip from the body of the catheter.