🏥 Medical Devices 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.
All Recalls
95,094 total recalls in our database
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)
🏥 Medical Devices 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)
🏥 Medical Devices 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)
🏥 Medical Devices 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)
🏥 Medical Devices 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)
🏥 Medical Devices 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.
🏥 Medical Devices Class I - Dangerous
Exterior carton is mis-labeled as Sterile. Non-sterile, bulk specimen containers were packed in incorrect exterior carton.
🏥 Medical Devices 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)
🏥 Medical Devices 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.
Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets.
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)
🏥 Medical Devices 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)
🏥 Medical Devices 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.
🏥 Medical Devices 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.
CENTURION Vision System
Alcon Research
🏥 Medical Devices 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.
🏥 Medical Devices 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.
🏥 Medical Devices Class I - Dangerous
Lack of Assurance of Sterility: Internal dye ingress test failure to assure the integrity of the vial.
🏥 Medical Devices 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.
🏥 Medical Devices 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.