Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1 FS, 4600 and 5600 Chemistry Systems when using Calibrator Kit 9, Lot 954. A trend of complaints regarding customers actions following U90-382 or 6LU condition codes was noted (See RES 72289 - VITROS Calibrator Kit 9, lot 954 recall).
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Diagnostic Equipment
🏥 Medical Devices • 6,627 recalls
GE Healthcare has updated the Service Manuals for a number of CT and PET CT Scanners to update an incorrect torque value.
Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1 FS, 4600 and 5600 Chemistry Systems when using Calibrator Kit 9, Lot 954. A trend of complaints regarding customers actions following U90-382 or 6LU condition codes was noted (See RES 72289 - VITROS Calibrator Kit 9, lot 954 recall).
Class I - Dangerous
ADVIA Centaur Systems Calibrator E Lot 42 and 43 Bias with the Testosterone Assay
This is related to previous 806 Notifications about uncommanded movements of a motorized mobile x-ray system. Reason for Recall: Along with the previously noted encoder and gauges problems and corresponding fixes, we have observed that static electricity can also elicit the unwanted behavior.
The firm has become aware of the potential for disruption (flickering) in the video laryngoscopy image when GlideScope Titanium SU laryngoscope blades are in use. Video "flickering" appears as the intermittent break-up of the on-screen video image, appearing as either distorted horizontal or vertical bars of displaced video signal.
Class I - Dangerous
ADVIA Centaur Systems Calibrator E Lot 42 and 43 Bias with the Testosterone Assay
Class I - Dangerous
The firm has received one report of values for patient height and weight being switched when input at the Xhibit Central Station, Model 96102, causing a bedside monitor Body Surface Area (BSA) calculation to be in error.
ADVIA Centaur Systems Calibrator E Lot 42 and 43 Bias with the Testosterone Assay
Screws holding the detector panel in as a result the detector panel could make contact with other parts with in the 0-arm¿ 02 Imaging System, causing noise and vibration when being positioned or during 3D Imaging could lead to poor image quality
Arrow has issued a recall for these products due to potential packaging damage. The sterility of the products cannot be guaranteed. If non-sterile product is used there is a potential for infection to occur.
Class I - Dangerous
Customer complaints about failed target ranges for alpha angle. Firm has not completed the CAPA identifying the root cause. Projected completion of the CAPA by the firm is July 2016.
Potential for higher than specified surface temperatures. Use of 3.0T GEM Flex system may result in patient warming or burns.
Product potentially exposed to body fluids during processing. Potential adverse events that may occur as a result of the foreign matter include blood borne pathogen transmission. However, the risk of transmission of blood borne pathogens is thought to be minimal to non-existent since these devices were sterilized after the potential exposure to body fluids.
PINPOINT Endoscopic Fluorescence Imaging System
Novadaq Technologies
Class I - Dangerous
It has been determined that the PINPOINT Operator's Manual does not contain validated parameters for gravity-cycle autoclave sterilization of the PINPOINT laparoscopes and light guide cable in the reprocessing tray.
BrightView are gamma cameras; Designed for single or dual detector nuclear imaging.
Philips Medical Systems (Cleveland)
Class I - Dangerous
The firm discovered four issues with the BrightView Family systems. Issue 1: During a cardiac non-Auto Body Contouring (ABC) scan, using Cardiac High Resolution (CHR) collimators, the collimator may come in contact with the bottom edge of the patient pallet. If this occurs, collision sensors would pause the scan. Issue 2: During a scan, the gantry motion may halt prematurely. This cause
BrightView X are gamma cameras; Designed for single or dual detector nuclear imaging.
Philips Medical Systems (Cleveland)
Class I - Dangerous
The firm discovered four issues with the BrightView Family systems. Issue 1: During a cardiac non-Auto Body Contouring (ABC) scan, using Cardiac High Resolution (CHR) collimators, the collimator may come in contact with the bottom edge of the patient pallet. If this occurs, collision sensors would pause the scan. Issue 2: During a scan, the gantry motion may halt prematurely. This cause
Class I - Dangerous
Siemens Healthcare Diagnostics has confirmed an increase in the rate of Abnormal Assay errors and calibration failures with the Dimension Vista B2MIC Flex reagent cartridge: Dimension Vista System Flex reagent cartridge and urine stabilizer B2MIC. In the unlikely event that a patient result is generated, a suppressed result would be in conflict with the patients clinical status and other markers of renal injury.
Olympus, Model No. GIF-H180J, flexible scope, large diameter, video gastroscope
Integrated Medical Systems
Class I - Dangerous
If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.
Olympus, Model No. CF-Q140L, flexible scope, large diameter, video colonoscope
Integrated Medical Systems
Class I - Dangerous
If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.