Bigger-Better-Bladder With 3/8" ID tubing, ITEM BBB38
Circulatory Technology
Class I - Dangerous
The seal between the balloon and the housing may leak.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
Direct Supply aluminum crutch, adult, 1 pair per case Aid the user in walking while relieving weight from one foot or leg.
Medical Depot
Class I - Dangerous
Tip crutch failure involving the bottom of the metal portion which comes in contact with ground
Universal aluminum crutch, 1 pair per case Aid the user in walking while relieving weight from one foot or leg.
Medical Depot
Class I - Dangerous
Tip crutch failure involving the bottom of the metal portion which comes in contact with ground
Class I - Dangerous
As a result of an internal review of all labeling for the Cadence System, it was determined that the outer package label for the Size 5 Left Tibial Tray Implant reflects the material composition incorrectly. The labeling incorrectly reflects the material as Cobalt Chromium instead of Titanium.
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
It is possible that that the selected Plan-of-the Day could be accidently changed by scrolling the mouse wheel up and down and inadvertently selecting another plan.
The surface inside of the femoral component, where cement is applied for adhesion, is below specification.
Class I - Dangerous
Possible presence of foreign material (rust).
The surface inside of the femoral component, where cement is applied for adhesion, is below specification.
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.
Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets.
The surface inside of the femoral component, where cement is applied for adhesion, is below specification.
Brilliance iCT model #728306; 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.
Brilliance CT Big Bore Oncology, model #728243; 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 and cause injury to patients, operators, by standers or service personnel.
Ingenuity Core 128, model #728323; 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.
Brilliance 64, Computed Tomography X-ray system Product Usage: The Brilliance CT 64 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 Brilliance 64 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.
Big Bore Oncology tomography X-ray system scanner, model number 728243. The Big Bore Oncology 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
Socket Head Cap Screws (SHCS) used in the Z-Axis Adjustment Plate were found to be made of stainless steel rather than the specified alloy steel.
Class I - Dangerous
Exterior carton is mis-labeled as Sterile. Non-sterile, bulk specimen containers were packed in incorrect exterior carton.
Class I - Dangerous
Demonstrate an upward shift in patient results.
Ingenuity Core 128-Computed Tomography X-ray system Product Usage: The Ingenuity Core 128 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 Core128 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.