Medical equipment, implants, and diagnostic devices
R & D Systems
The kit was provided without a copy of the lot-specific kit booklet and the Calibrator 0 vial 18D1/4 label incorrectly specified reconstitution volume of 2mL.
Product may not meet the internal manufacturing shaft subassembly burst strength specification (Failure of the Burst Shaft Test).
There is a potential for comingling of the 43MM and 51 MM molds
Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.
Incorrect package labeling identifying the device
Thermal chamber motors have electrical cables with single insulation rather than the required double insulation. There is no exposed current due to the single insulation that could result in a potential electrical shock
Abnormally high INR test results with the affected CoaguChek test strips
Vials of the autoHDL/LDL Calibrator were shipped without a vial label.
A robotics supplier notified Accuray of two manufacturing variations in the fastening of the in-line wrist and the casting of the wrist for the robot. The variation may result in premature failure of the component.
Safe N Simple
The sterilization process used was unqualified.
The reagent pack exhibits the potential for an increased frequency of calibration failures.
An issue with the power branching printed circuit board (PCB) on the instrument that has the potential to trigger a heater malfunction was discovered. If this failure were to occur, nucleic acid extractions could be compromised and extractions need to be repeated. This could cause a delay in obtaining results from downstream applications.
ParaPost Plus Titanium Posts contain stainless steel post that are a size 4
Potential for clear extension tube to separate from the hub, which could result in blood loss and may require intervention to prevent permanent impairment/damage
Medtronic Navigation, Inc.-Littleton
O-arm 02 Imaging Systems correction to software version 4.1.0; new version of the user manual and an Image Acquisition System ("IAS") product label; replacing blown fuse of the new AC power input circuit
Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.
Incorrect package labeling identifying the device
Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.
The products have the potential to leak between the connection of the male luer lock and the yellow striped tubing.
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Vulnerabilities have been identified in the SDN download process that may allow an individual with malicious intent to update the programmers with non-Medtronic software during an SDN download.