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Distal tip may become detached from the device
Microalbumin Multi Calibrator mislabeled label on Level 5 and Level 6, cap label correct
VHS Plate and lag screw components did not assemble correctly intraoperatively.
The Meridian pump is less likely to detect small pressure changes, which may indicate the presence of a post-pump tubing kink, when using pre-pump arterial pressure monitoring.
Potential issue with annotation function. Annotations, shown as overlays, may change font size when the image is saved. Text may appear shifted, or lines appear thicker, and their position may not be as intended.
Mislabeling: Anti-CD45 cocktail antibody mislabeled as Ki-67.
Wrong size capacitor installed in electrosurgical generator could malfunction, causing muscle stimulation or delay in therapy.
The VerifyNow P2Y12 assay can report an erroneous result instead of an error message when a sample with low hematocrit is run.
Reports were received of the ball ring ejecting from the connector's body when other connectors have already been locked down.
Leksell Gamma Knife C 1.2 with MCU version 4.0.0.6 improperly adjusted trolley for 4mm helmet caused jamming when helmet changer attempted to lock helmet. Lock did not fully engage and could still be raised. When the lock does not engage, then when the helmet changer rises, the helmet could disengage from the helmet changer and fall back onto the helmet trolley.
Users may experience one or more of four (4) problems; 1. Image quality problem with full leg full spine exams. 2. Unable to print 2 or more images on 1 film. 3. Possible image loss when printing. 4. Study date and time not showing up on Imexius Web.
The hand crank necessary for the emergency manual operation of the pump is too wide diametrically to fit into the holes which they were designed to fill.
Reports of low calibration rate value flags; Use of the recalled product may result in failure to calibrate the instrument
Improperly machined parts: The Cemented Finned Tibial Trays could not seat the size 2 mating trial or polyethylene insert.
Directions for Use-Puritan Bennett has determined that a service interval should be defined for the device. The firm has also determined that an exhalation filter should be employed when the device is in use.
The PT2 J-tip labeled guide wires may be missing the pre-formed J-tip. As a result, guide wires may have a straight tip instead of a pre-formed J-tip.