Medical Devices Recalls

A defect in CAS I/II Absorbers in the Spacelabs Anesthesia Workstations and Service Kits may cause a condition leading to an increase in the carbon dioxide concentration within the inspired gas being delivered to the patient.

The rods were incorrectly laser etched as ILLICO¿ Straight CP Tl Rods, 110mm, when they were in fact manufactured to 100mm in length.

Received 2 complaints out of 458 distributed pumps in this lot, where flow restrictor bead became displaced, which were reported to permit fast flow of contents.

Mislabeled: Genesis Straight Esthetic 4.0mm Contour ,1mm cuff labeled as Genesis Straight Esthetic 5.0 mm, 3mm cuff abutment

Sporadic hang-up malfunctions concerning 3D reconstructions during activated "Preview Image" functionality.

A locking nut might loosen out of the overhead Video Monitor Suspension yoke affecting Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, and Innova 4100IQ Cardiovascular X-ray imaging systems.

In certain situations a software problem with the TotalCare SpO2RT¿ 2 bed may occur that can lead to inadvertent loss of sufficient surface cushion pressure to adequately support the patient. This may increase the likelihood of skin irritation for patients at higher risk of developing pressure-related skin conditions. A correction to the software program is currently being developed and tested,

Natus Neurology Incorporated is recalling the Nicolet EEG Wireless Amplifier which may overheat and become uncomfortable to touch around the area of the on/off button. The overheating may result in discomfort ranging from too hot up to the potential for a burn.

The displayed value for the invasive blood pressure measurement of the IACS was different than the actual patient values. Liquid ingress in the cable connection may cause inaccurate measurements. This can happen if the Dual Hemo MCable is used in a non-vertical position, a vertical position but upside down, or laying it on the floor or on the patient bed.

Mislabeled: Genesis Straight Esthetic 5.0mm Contour ,3mm cuff labeled as Genesis Straight Esthetic 4.0 mm, 1 mm cuff abutment,

75 mm screws were packaged and labeled using an 80 mm screw outer box and label, while 80 mm screws were packaged and labeled using a 75 mm screw outer box and label.

Lot number 7542279, of the 45 mm Click 'X Pedicle Screw (Part number 487.072), was incorrectly etched as "Click 'X Pedicle Screw 05.2 L40 TAN violet" although the actual length of the screw is 45 mm.

The DICOM tags do not contain sufficient information for XVI to identify the different volumes that have the same name.

Potential failure of the braking system that controls the O-arm Imaging System gantry movement in the vertical direction

Exposed high voltage wires inside the cabinet . On a cable located in the system cabinet, two of the shrink tubings covering the 400V live cable leave an area potentially unprotected.

The Straight Ringloc Button Latch Inserter Handle may have been manufactured at the higher end of the tolerance causing interference with the Ringloc cup. The inserter handle may lock onto the cup during impaction. If alternative inserters are not available this could cause a surgical delay greater than 30 minutes.

A portion of a silicone wound drain was found to be cracked.

Two production orders of these IOLs that contain mislabeled IOLs.

Diagnostica Stago has confirmed that sometimes the delta OD measured can be changed leading to a lowered percentage result.

Multiple incidents of low-reacting assay plates.