Medical Devices Recalls

The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch

The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch

The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch

The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch

Handle may break during use.

Handle may break during use.

A gap in the housing of the wireless foot switch could potentially result in liquids penetrating the interior. Such liquids may include disinfectants, cleaning agents and/ or bodily fluids. In rare cases, the introduction of liquids in the wireless foot switch housing could result in the failure of the foot switch.

Handle may break during use.

Four issues: 1. Motion controller problem stops scan and no data image produced. 2. Door interlock switch problem disables CT scan. 3. Detector contacts head holder when performing Patient Unload. 4. JETStream freezes during gated planar scan

Reports that the sample type "cord blood" has been changed into the two sample types "cord blood arterial" and "cord blood venous.

CareFusion is recalling the MaxGuard Extension Set with Injection Site and 0.2 micron filter because of reports of separation and/or leakages between the Y-connector and tubing.

Terumo CVS initiated a voluntary recall for the Level Sensor II Pads and Level Sensor Gel Pads due to non-compliant labeling because the product expiration date is displayed in a format that may not be recognizable to all users.

20 Pumps sold to the Finnish market contain a message in which one word in the message is mistranslated. When the user follows a specific set of key presses the pump will display the incorrect message. The message indicates that a Patient Controlled Analgesia (PCA) dose is unavailable because the pump is running. It should indicate that the PCA dose is not available because the pump is stopped. The function of the pump is unchanged and no patient injury can occur since no drug is being delivered.

Handle may break during use.

The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch

The software produced a number of "do not route" exceptions, which may result in potential patient injury or delay in diagnosis or treatment.

Guide wires sized as .045 X 6 were mis-packaged as .054 X 7 guide wires and those sized as .054 X 7 were mis- packaged as .045 X 6 guide wires. There is a possibility that using the incorrect guide wire size can cause health hazards, such as mal or nonunion, need for revision surgery, and histological response (if wire breaks).

CareFusion is recalling the MaxGuard Extension Set due to reports of leaks occurring with the 0.2 micron filter.

Four issues: 1. Motion controller problem stops scan and no data image produced. 2. Door interlock switch problem disables CT scan. 3. Detector contacts head holder when performing Patient Unload. 4. JETStream freezes during gated planar scan

OEC FlexiView 8800 workstation power cable assembly issue which can result in a loss of imaging functionality due to intermittent power cord failures.