Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
Ingenuity Core-Computed Tomography X-ray system Product Usage: The Ingenuity Core scanner is a whole body Computed Tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
Philips Medical Systems (Cleveland)
Class I - Dangerous
Philips Healthcare received reports from the field that certain Ingenuity Core systems running software version 3.5.4 exhibited intermittent swirl-like ring artifacts that may appear on reconstructed images. A patient rescan may be required if the images cannot be used for interpretation due to the swirl-like artifact.
Ingenuity Core, model # 728326; Intended to produce cross- sectional images of the body.
Philips Medical Systems (Cleveland)
Class I - Dangerous
Supplier design change contributed to a thinner plastic which was used as part of the cover on the devices. The thinner plastic cover may crack causing injury to patients, operators, by-standers and service personnel.
Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.
CENTURION Vision System
Alcon Research
Class I - Dangerous
The grounding pin within the Power Entry Switch on certain systems was susceptible to detachment when the AC power cable is removed.
Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.
Class I - Dangerous
Lack of Assurance of Sterility: Internal dye ingress test failure to assure the integrity of the vial.
Class I - Dangerous
Deterioration in performance of the Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT resulting in under recovery. The manufacturer has indicated that the HOMOCYSTEINE REAGENT lot listed above shows deterioration in assay performance manifesting itself by under recovery of Homocysteine in Controls and Patient Samples. The cause of this deterioration has been attributed to a loss of reductant activity in Reagent 1. Testing performed indicated that the affected lot is at the limit of acceptable clinical performance. This observation was consistent across the reportable range of the assay. For this reason, do not continue to use affected reagent lot. Test data generated to date will be acceptable where validity control specifiCations have been met.
Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.
Class I - Dangerous
Tip crutch failure involving the bottom of the metal portion which comes in contact with ground
The surface inside of the femoral component, where cement is applied for adhesion, is below specification.
Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets.
Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets.
Possible presence of foreign material (rust).
Class I - Dangerous
Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.
Class I - Dangerous
Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.
Class I - Dangerous
Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.
An incorrect HER2 probe concentration was used when producing the probe component (Vial 3) in this kit lot. This has resulted in the HER2 probe concentration being too low.
SYNGO Breast Care, visualization and image enhancement tools to aid radiologist in the review of digital Mammography images and tomosynthesis datasets.
Siemens Medical Solutions USA
Class I - Dangerous
Software issues. Siemens is voluntarily initiating a recall after they became aware of the following system behavior: 1) At times, the view and laterality marker is overlaid by patient demographic information, thus becoming difficult to read. 2) The facility name and address are not shown per default (in the current software versions this information is displayed only when the reader chooses an appropriate image text display mode).
Class I - Dangerous
Premature bucket failures