Infusion Pumps

Evidence supports that when customers performed a fuse replacement as part of a March 2017 field action, the fuse clips became stretched and were no longer mechanically tight with the fuse, creating a host spot that led to discoloration on the board due to overheating and shut down of the device.

There is a potential that Wedge IDs were not included in the DICOM RT PLAN sent from the TPS, which will cause the field in MOSAIQ to be created with no wedge. Treatment of a field without the planned wedge will receive more dose than the treatment plan indicates.

This action has been initiated to address complaint reports received for crimp balloon and inflation balloon component separation during TAVR procedures.

Samples tested using ARCHITECT Free T3 or ARCHITECT Total T3 assays may show depressed results due to a reagent carryover when testing on board with specific assays on the ARCHITECT i1000SR and i2000/i2999SR platforms.

Samples tested using ARCHITECT Free T3 or ARCHITECT Total T3 assays may show depressed results due to a reagent carryover when testing on board with specific assays on the ARCHITECT i1000SR and i2000/i2999SR platforms.

The internal labeling included with these implants may include incorrect part numbers and could result in these incorrect labels being added to patient records.

The internal labeling included with these implants may include incorrect part numbers and could result in these incorrect labels being added to patient records.

There is a risk of detachment of the Compact Gantry Rolling Floor.

Dental varnish has the possibility of having an unpleasant and off flavor.

The Human sTfR Quantikine IVD ELISA Kit, catalog # DTFR1, lot P180151 was packed with the incorrect control data card number 750228.4.

Potential for leakage due to defect in the thermoset check valve component.

If a Setup field (CT, kV, MV or MVCT) is created by COPYING a treatment field or another setup field, then the copied field will have the same isocenter as the parent and that isocenter may not be the correct isocenter for imaging when it is sent to the machine.

Potential for leakage due to defect in the thermoset check valve component.

Potential for leakage due to defect in the thermoset check valve component.

Potential presence of rust on Coupler Forceps (GEM4183C).

Issue #1 affects Software Versions 6.0 SP7, SP7.0.1, SP7.0.2, SP7.0.3, SP8, SP8.0.1, SP8.0.a and SP8.0.2. When an image is flipped horizontally and vertically, the orientation markers appear correctly on the image to which they were applied. However, once new image rendering happens on this image or series (with scrolling; playing cin¿; maximizing or changing viewports/layouts; or synchronizing viewports and resizing the browser), the new image orientation is correctly maintained but the display of orientation markers can become incorrect. Issue #2 affects Software Versions 6.0 SP7, SP7.0.1, SP7.0.2, SP7.0.3, SP8, SP8.0.1, SP8.0.a, SP8.0.2, SP9 and SP9.0.1. When an image in a series is flipped and then rotated in Zero Footprint Viewer (ZFP), the orientation markers appear correctly on the image to which they were applied. However, once you navigate to another image in the series and the image you navigated to has a different orientation than the prior image from which you navigated, the new image orientation is correctly maintained but the display of orientation markers can become incorrect.

Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent.

The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip remaining in the patient.

There have been reports of distal occlusion alarms during the use of SAPPHIRE Epidural Set Yellow-Striped administration sets.

The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip remaining in the patient.