Other Medical Devices

If a user-generated preset for an 18L6 transducer created on a 1.0 ultrasound system is used with a 2.0 ultrasound system, the 2.0 ultrasound system will display underestimated measurement results when using an 18L6 transducer and viewing in the Dual format visualization function, which may lead to misdiagnosis of a patient's condition or influence patient management decisions in a negative way.

Ultrasound gel mislabeled with inappropriate use.

A bottle of Copaliner Solvent was inadvertently packaged into a box labeled as Copaliner Varnish (0921526) and sold as Copaliner Varnish (0921526).

The incorrect product labeling was applied to the product indicating the wrong size of product.

Ultrasound gel mislabeled with inappropriate use.

The Hard Line Chairside Reline Kit (570-0718) (0921940HS) was labeled as Soft Line Chairside Reline Kit (570-0717) (0921250HS) on the outer box. The contents of the Kit and the IFU enclosed with the kit were correctly labeled as Hard Line materials

On lot of Todd Hewitt Broth w/CNA (LIM) may exhibit no recovery of target organism during customer QC testing or use with patient samples

Ultrasound gel mislabeled with inappropriate use.

Manufactured lenses are not covered by existing FDA approval

The Distal Attachment contain di-2-ethylhexyl phthalate (DEHP), which exceeds the permissible exposure level calculated according to ISO 10993-17: 2002

A foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation

GI Software labelled as revision 3.3.0 is incorrectly labeled and is in fact revision 3.2.0.

A foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation

Manufactured lenses are not covered by existing FDA approval

Transducer, an ultrasound system accessory, consists of two parts that are bonded together that may come apart due to chassis bonding issue, which may pose risk to users and patients of tissue damage, and electric shock if the built-in safety measures to prevent electric were to also fail.

The Distal Attachment contain di-2-ethylhexyl phthalate (DEHP), which exceeds the permissible exposure level calculated according to ISO 10993-17: 2002

A foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation

Sterility of device may be compromised due to breach of the chevron seal of the packaging

Trocar manufactured with the shaft too long and does not meet manufacturing specifications. As a result, when used with the 30¿ neuroendoscope, a portion of the visual field is obscured.

Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.