Other Medical Devices

The kits contain surgical gowns which were subject to a recall by the supplier.

A labeling discrepancy incorrectly labeled AMS 700 100mL Conceal Low Profile Reservoir with InhibiZone as 100mL Spherical Reservoir with InhibiZone.

The firm has become aware through their optical laboratory supplier that prescription spectacle lenses within various frames failed to meet safety specification for shatter resistance. This could result in cracked or broken lenses.

Nonconforming product; length of the product measured shorter than the labeled length.

A defect in the SATA power adapter cable within the instruments 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 computers metal enclosure, smoke emanating from PC6, flames contained within PC6, or an inability to use the devices CD-ROM.

Genicon is providing updated IFU labeling to users to provide clarity on how to use the device for multiple specimen retrieval.

Due to programming errors in the Controller, an increase in the set motor parameters can be made by the end user beyond tested safe limits.

There is a potential that an image from a previous patient study to show up in a later patient study. This may result in misdiagnosis of the correct patient.

labeling error: Due to a manufacturing issue, product package was incorrectly labeled with the incorrect sheath size and the incorrect sheath assembly was included in the product packaging. The use of the incorrect kit components may result in vasoconstriction, moderate hemorrhage, and/or embolism.

The sterile single-use tubing may contain higher ethylene oxide (EO) residues than the acceptable level.

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.

Ambulance Cots may not meet crash test standard BS EN 1789

Potential for out of range microbial results

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.

The devices were mislabeled with the incorrect product size resulting in 16Fr devices being labeled as 14Fr devices.

The FlexLab Centrifuge Module loading algorithm may lead to unbalanced loads which could damage the centrifuge.

There is a potential that IV administration sets contain a 15 drops/mL drop cannula instead of a 10 drops/mL drop cannula within the drip chamber. An infusion set with an incorrect drop cannula could result in inaccurate delivery of the intended infusion volume (under-delivery). This could result in under-delivery of critical medication which may lead to serious adverse health consequences.

The locking mechanism of the tibial tray exhibited a manufacturing defect in which a uniform ridge was cut along the inner wall of the "T" and "Y" junctions, which may cause resistance when the Tibial Insert was being assembled.

The bolt affixing the cooling unit to the rotor was not tightened to specification on the Philips Brilliance iCT systems.

The bolt affixing the cooling unit to the rotor was not tightened to specification on the Philips Brilliance iCT systems.