Medical Devices Recalls

When excessive amounts of urine spills on the rack transport track and reaches the electrical components of the CV-11 conveyor, there is a potential for smoke and/or sparks which may present a combustion hazard.

Scanning may be interrupted due to an error during execution of the eXam Plan and the system is unable to be shut down normally, resulting in the need to forcibly turn the system power off and reboot. Loss of the acquired raw data would occur.

Software mismatch-When the software versions between the SP-50 and CF-70 are not matched, and an error condition occurs requiring the operator to open the cover door of the CF-70 to remove slides or slide magazines from the CF-70, the operation of the CF-70 does not halt.

Corrections are being made to the device labeling regarding its intended use, to include a statement clarifying it is for research purposes only.

Scanning may be interrupted due to an error during execution of the eXam Plan and the system is unable to be shut down normally, resulting in the need to forcibly turn the system power off and reboot. Loss of the acquired raw data would occur.

Updated Instructions For Use- to contraindications and potential complications/adverse events of the colonoscopy procedure (without using Endocuff Vision Device)

Concerned lot of VACETTE 2mL 9NC Coagulation Tubes were shown to have inconsistent amounts of the 2.3% sodium citrate.

Scanning may be interrupted due to an error during execution of the eXam Plan and the system is unable to be shut down normally, resulting in the need to forcibly turn the system power off and reboot. Loss of the acquired raw data would occur.

Scanning may be interrupted due to an error during execution of the eXam Plan and the system is unable to be shut down normally, resulting in the need to forcibly turn the system power off and reboot. Loss of the acquired raw data would occur.

Scanning may be interrupted due to an error during execution of the eXam Plan and the system is unable to be shut down normally, resulting in the need to forcibly turn the system power off and reboot. Loss of the acquired raw data would occur.

Scanning may be interrupted due to an error during execution of the eXam Plan and the system is unable to be shut down normally, resulting in the need to forcibly turn the system power off and reboot. Loss of the acquired raw data would occur.

Lots of Smiths Medical Portex Pro-Vent and LineDraw Arterial Blood Sampling syringes may have broken luers.

A nonsterile bulk product designated for further processing in a tray was inadvertently shipped to a customer.

The firm initiated a voluntary correction of certain Cosman TCN Electrodes due to an incorrect revision of the Instructions for Use (IFU) being packaged with these products.

Scanning may be interrupted due to an error during execution of the eXam Plan and the system is unable to be shut down normally, resulting in the need to forcibly turn the system power off and reboot. Loss of the acquired raw data would occur.

Portex Pro-Vent and LineDraw Arterial Blood Sampling syringes may have broken luers.

Extended Expiration Date prior to clearance

Extended Expiration Date prior to clearance

The retaining ring on the neck trials has a potential to fail interoperatively.

Extended Expiration Date prior to clearance