Medical equipment, implants, and diagnostic devices
Neonatal Valves were manufactured with a ventricular catheter connection site shorter than the design specification. The defect can lead to difficulty in securing the valve to the proximal catheter which could result in disconnection of the ventricular catheter from the valve and shunt malfunction
The catheter may become susceptible to distal tip damage during use. Distal tip damage in conjunction with pressurization of contrast injection may result in potential vessel damage, and subsequent patient injury or death.
The instruments may become cold welded together when the drill is inserted through the Soft Tissue Guide. This prevents disassociation of the instruments and potentially leads to an increased chance of fracture of the drill.
The catheter may become susceptible to distal tip damage during use. Distal tip damage in conjunction with pressurization of contrast injection may result in potential vessel damage, and subsequent patient injury or death.
Neonatal Valves were manufactured with a ventricular catheter connection site shorter than the design specification. The defect can lead to difficulty in securing the valve to the proximal catheter which could result in disconnection of the ventricular catheter from the valve and shunt malfunction
A discrepancy was found between the Mixing Instruction Card and the Instructions for Use for the 5cc and 10 cc bone void filler kits. No customer complaints or reports of injury have been received.
Roche Molecular Systems
When a user creates a measurement tool annotation in the uPath Enterprise software version 1.1, the measurement value is incorrectly calculated when the measurement is viewed in "Split View" viewing mode and the slides within the case are scanned at different magnifications.
Potential for incorrect Instructions For Use (IFU) included with an Equinoxe Humeral Stem, Primary, Press Fit, 11mm package.
The Magstim Company Limited
A small number of Neurosign 100 Intraoperative Nerve Monitors may have been dispatched without being configured appropriately for the supply mains within the target Country. The specific deficiency includes: 1. Onboard voltage selector set to 240V (European Standard), versus 120V requirement for the United States and Canada. 2. Fuses installed in the Power Entry Module (PEM) 2xT315mAL (240V Standard), versus the 2xT630mAL requirement for a 120V mains supply.
The electrical contactor component present in the drying chamber of the Reliance Vision Single-Chamber Washer/Disinfector may malfunction, potentially leading to the heating elements in the drying chamber to overheat, eventually resulting in smoke and/or fire.
Ionized calcium test on some i-STAT CG8+ and EG7+ cartridges may exhibit higher than expected reported results when stored at room temperature (18 to 30C) for periods of time in excess of 3 days for lot numbers *20100 to *20339 and 7 days for lot numbers *20340 and above Where * = lot letter A, K, L, M, N, W or Y.
Roche Diagnostics Operations
A software error results in the unintentional removal of the serum-indices flag that would otherwise prevent the release of results. The Cobas Inifinity has an auto-verification feature to hold results for manual review when they meet specific criteria. The serum indices flag is used for serum indices tests that are performed to assess the quality of the sample (e.g. hemolysis, icterus, and lipemia). Normally, when the Cobas Infinity receives a result for a test that is serum indices-sensitive, it flags the result and the software then waits for the results of the serum indices tests before validating or rejecting the test result. Roche has discovered a software error that under specific conditions causes the flag to be incorrectly removed. This allows for the possibility that a sample of poor quality may return an unreliable/incorrect test result that is mistakenly reported to the health care provider and/or patient without the proper disclaimer that the result is based on a sample of poor quality.
Shipping box may contain wrong model.
Neonatal Valves were manufactured with a ventricular catheter connection site shorter than the design specification. The defect can lead to difficulty in securing the valve to the proximal catheter which could result in disconnection of the ventricular catheter from the valve and shunt malfunction
The catheter may become susceptible to distal tip damage during use. Distal tip damage in conjunction with pressurization of contrast injection may result in potential vessel damage, and subsequent patient injury or death.
Beckman Coulter
The Quality Control (QC) card has a label error for the standard deviation (SD) values for one out of the two levels of QC.
A discrepancy was found between the Mixing Instruction Card and the Instructions for Use for the 5cc and 10 cc bone void filler kits. No customer complaints or reports of injury have been received.
Boston Scientific
Boston Scientific (BSC) is retrieving five Model 7060 ACUITY cutters distributed in the US that did not undergo the applicable sterile processing procedure.
The catheter may become susceptible to distal tip damage during use. Distal tip damage in conjunction with pressurization of contrast injection may result in potential vessel damage, and subsequent patient injury or death.
Fujifilm Medical Systems U.S.A.
There is a potential for the wrong patient information may be displayed in the viewer or PowerJacket. Additionally, the incorrect max standard uptake values (SUV) for PET ad CT studies may be returned for Siemens Modality.