Other Medical Devices

Error in the software. A deviation between reconstructed and planned dose distribution may not be detected prior to treatment and this can result in an over or under-estimation of the pretreatment delivered dose.

Particulate matter found inside the fluid path.

Positive bias for Calibrator E lot kits ending in 38 and 39 with the ADVIA Centaur Systems Cortisol and Progesterone assays compared to the respective master curves.

Particulate matter found inside the fluid path.

The single leg of the PAY connector has been observed to become detached.

If the laser system is turned on and the user adjusts, installs or removes the XPL pulsed light handpiece, there is a potential risk of an electrical shock

While the Proteus 235 is in the pencil beam scanning (PBS) treatment mode, on rare occasions, Low Level Radio Frequency (LLRF) pulsed dee voltage (i.e., voltage applied between two electrodes in the cyclotron to accelerate protons) may generate a hot spot on a pencil beam position within a tumor, generating a dose that might exceed the prescribed dose on a single voxel.

Coloplast is recalling the Conveen Contour Leg Bag due to potential leakage from the bag seam when filled.

Elekta has become aware that the latches may be locked before they have been fully turned resulting in a poorly locked frame.

A recall of the APTUS Ulna Shortening 2.5 instrument was initiated due to three (3) complaints of breakage of the temporary tension bolt.

CooperSurgical is recalling two lots of 900-863 because the wrong package insert (IFU) was placed into the shipper.

Distortion (noise interference) of the liquid level capacitance can result in air aspiration instead of liquid aspiration. This might cause a false signal (air detection) with possible dispense errors resulting in erroneous results.

Routine quality monitoring system has identified that a limited number of lots were manufactured with the cylinder axis outside the allowable specification.

SAM Junctional Tourniquet (SJT) Auxiliary strap, model SJT 102 and SJT 112, is recalled because the snap hook on auxiliary strap broke during training demonstration.

Product lot did not meet the specification for its disinfectants at the time of manufacture.

The Easy-Care Care-Lock feature installed at the foot of the bed may potentially fail to stay engaged (locked) after the Care-Lock System has been engaged by stepping on the red (locked) pedal.

Package inserts have incorrect SmartWash parameters for Triglyceride.

There have been 5 customer reports of a 501-1018 series DMI Rollator Transport Chair collapsing during use.

Unintended movement of the operating table during surgical cases due to the use of damaged TITAN remotes.

In March, Siemens Healthcare Diagnostics issued an Urgent Medical Device Correction for decreased recovery of patient samples with the Dimension Vista® CSA & CSAE Flex® reagent cartridges when whole blood samples are run from Small Sample Containers (SSC). Siemens has confirmed that when whole blood samples are run from SSC, HbA1c values may exhibit a percent bias ranging from - 8.2% t