Medical device recalls

Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.

Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.

Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.

Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.

Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.

Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.

VITROS TSH reagent lots have been found to generate higher than expected Calibrator level 2 signals on some customer systems. These Calibrator Level 2 responses cause a higher than expected frequency of customer generated calibration curves to fall outside of the calibration quality parameter measuring the gradient of the Customer Calibration Curve between Calibrator Level 2 and Calibrator Level 3.

Certain lots of M-30D diluent used with BC-3200 and BC-3600 Hematology Analyzers and M-53D diluent used with BC-5390 Hematology Analyzer may cause the system to produce an elevated platelet background count.

Certain lots of M-30D diluent used with BC-3200 and BC-3600 Hematology Analyzers and M-53D diluent used with BC-5390 Hematology Analyzers may cause the system to produce an elevated platelet background count.

A component used within the braking system may break resulting in one or more brake pedals on the bed staying in brake or not being engaged which could result in unwanted bed movement and possible patient or user injury.

Product has been found with a missing Washer, Retaining Ring, and/or Stop Screw. Recalling firm was notified by distributor that Refractor Suspension Arm fell on a patient s lower torso along with the arm housing

One lot of D-RAD Self-Taping Locking Screws used with the Distal Radius Fracture Kit were machined out of specification. Screws measured over tolerance within the head thread form by 0.002-0.003 inch.

A programing error in some Model FD100 HomeSafe AutoAlert Pendants will render the fall detection feature inoperable.

The NBP measurement of Intellivue X3 Patient Monitor shows intermittently only mean values instead of the diastolic and systolic blood pressure values. This is caused by a falsely detected NBP cuff, which is leading to wrong internal NBP setting. Furthermore, occasionally the Monitor shows the Check Touch Input message and the monitor is inoperable with the touch interface.

Possible blood leaks through the hydrophobic portion of the Pall LG6NS LeukoGuard Leukocyte Reduction Arterial Blood Filters.

The stability specifications of ImmunoCAP Allergen c6, Amoxicilloyl were not met.

The stability specifications of ImmunoCAP Allergen c5, Ampicilloyl were not met.

Product exhibits a decreased recovery of patient samples on the cobas e 801 module compared to the MODULAR ANALYTICS E 170, cobas e 411, 601, and 602 analyzers.

Several instances of a catheter caught in the sterile barrier seal and in some instances cut catheters were observed.

Several instances of a catheter caught in the sterile barrier seal and in some instances cut catheters were observed.

Several instances of a catheter caught in the sterile barrier seal and in some instances cut catheters were observed.

The drill guides were manufactured with the incorrect color anodization.

The battery is integral to the device. If the device sits unused and is not charged for a lengthy period of time (a few months) the battery will go into a deep discharge state and the battery will expire. The battery may out-gas which may be described as swelled or puffed, as gas is trapped inside the pack surrounding the cells. This battery may cause the device case to separate a small amount.

The battery is integral to the device. If the device sits unused and is not charged for a lengthy period of time (a few months) the battery will go into a deep discharge state and the battery will expire. The battery may out-gas which may be described as swelled or puffed, as gas is trapped inside the pack surrounding the cells. This battery may cause the device case to separate a small amount.

A software functionality in the report sections Findings Information and Summary of Measured Findings is not performing properly. The system will use the original values instead of displaying and saving corrected/modified values. Outdated information could be sent to the referring physician when creating the formal report in the reporting system.

A database handling error could occur during the image acquisition process affecting the completeness of acquired images with Centricity PACS-IW. There is a potential that one or more image series (i.e. all images within an image set) may be missing from an exam without indication to the user. While this is rare, this can occur with imaging studies that consist of a very small number of images per series. E.g. CR Thorax exam with 1 image per series.

The product is not meeting the antigen excess protection claim of up to 760mg/L, as stated in the Instructions for Use.

Certain lots of the spinal cement may contain incorrect amounts of contrast medium so that the product is difficult or impossible to visualize on x-ray.

Product packaging may not be completely sealed.

Product packaging may not be completely sealed.