Diagnostic Equipment

Firm initiated recall because when radiographic conditions with the small focus are set and the radiography ready switch is held down, the large focus is also heated after a few seconds or more. This occurs when the Automatic Exposure Function (AEC) function is used. As a result, a radiographic tube current exceeding the set value flows and a brighter image than expected is acquired.

There is evidence that an electrical short within the systems connector has caused an accumulation of heat which has radiated back through the wiring harness causing the wires and connectors to melt.

There is evidence that an electrical short within the systems connector has caused an accumulation of heat which has radiated back through the wiring harness causing the wires and connectors to melt.

The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.

Philips Healthcare received reports from the field that certain Brilliance CT 64, Ingenuity Core, and Ingenuity Core128 systems running software versions 2.6.1 or 3.5.4 exhibited intermittent swirl-like ring artifacts that may appear on reconstructed images, which may impair the diagnostic quality of affected images.

The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.

There is evidence that an electrical short within the systems connector has caused an accumulation of heat which has radiated back through the wiring harness causing the wires and connectors to melt.

There is evidence that an electrical short within the systems connector has caused an accumulation of heat which has radiated back through the wiring harness causing the wires and connectors to melt.

Custom Procedural trays contain Medrad Hand Controller Sheaths which were recalled because the seal between the white polyethylene and the clear plastic may be missing on the package resulting in a potential breach of the sterility of this accessory.

GE Healthcare reported a potential safety issue due to temporary loss of X-Ray Imaging Modes during Collimator Auto-Calibration which affects Innova 3100 and Innova 4100 Systems.

Medical devices were incorrectly labeled with extended expiration dates.

Roche has confirmed the potential for an undetected elevated INR test result with the CoaguChek XS, CoaguChek XS Plus, and CoaguChek XS Pro meters. In rare cases, instead of a value, an ERROR 6 message is displayed.

If the operator selects a patient name from the worklist using the mouse and then selects a different patient name using the keyboard (arrow keys then press enter) the patient name that populates the exam information page is the patient name selected with the mouse. Also, it is possible to begin a normal clinical scan while the anti-virus scan is running. However, if the user is running a bol

While performing interval testing Ortho Clinical Diagnostics (OCD) determined that an excess amount of surfactant was unintentionally added to VITROS Chemistry Products CRP Slides during the manufacturing process.

Roche has confirmed the potential for an undetected elevated INR test result with the CoaguChek XS, CoaguChek XS Plus, and CoaguChek XS Pro meters. In rare cases, instead of a value, an ERROR 6 message is displayed.

GE Healthcare become aware of 4 potential issues associated with the CARESCAPE Monitor B850. These issues include CARESCAPE Monitor B850 uDOM failure, CARESCAPE Monitor B850 unstable USB communication, CARESCAPE Monitor B850 remote printing issue with currently printing PRN 50 recorder and CARESCAPE Monitor B850 reboots due to an X server freeze.

While performing interval testing, Ortho Clinical Diagnostics (OCD) determined that a surfactant was unintentionally added to VITROS Chemistry Products K+ Slides during the manufacturing process.

The firm is recalling these power cables due to a latent design reliability issue and the potential for shorting which can result in heating/melting of the cable jacket.

Internal testing found certain Sarns" TCM II systems were released with incorrectly assembled heatsink assemblies which could cause the units to fail.

Roche has confirmed the potential for an undetected elevated INR test result with the CoaguChek XS, CoaguChek XS Plus, and CoaguChek XS Pro meters. In rare cases, instead of a value, an ERROR 6 message is displayed.