Other Medical Devices

Products labeled as sterile were distributed, but may not have been sterilized.

When using more than one plan in a treatment course, the Total dose display in Dose tracking may be incorrect. There may be a mismatch between the fractions that appear as selected in the Treatment course list in Dose tracking and the fractions that are included in the dose summation. The issue only affects RayTreat users and only the Total dose option. Accumulation and other options in Dose tracking are correct.

For some LINAC types, merging clinical beams with beams of approximate dose may lead to the approximate dose erroneously labeled as clinical dose. Merge beams can be used manually, in scripting, or as part of the Automated breast planning feature. In some cases, when merging two beams where the first beam has clinical dose and the second beam has approximate dose, the dose of the resulting beam will be labeled as Clinical, although dose for some of the beam segments is still calculated with the SVD dose engine and it should be labeled Approximate: Mixed dose. The difference between approximate and final Clinical dose is in most cases small, but there can be body sites such as lung where the difference can be significant.

Products labeled as sterile were distributed, but may not have been sterilized.

Products labeled as sterile were distributed, but may not have been sterilized.

Products labeled as sterile were distributed, but may not have been sterilized.

Recall reason is possible sporadic false negative conventional troponin results. Roche has confirmed an issue with running Elecsys Troponin I/Troponin I STAT and Elecsys proBNP II/proBNP II STAT on the cobas e 601 and 602 modules. When the proBNP II analyte is measured immediately before the Troponin I analyte on the same module, a decreased recovery on Troponin I was observed.

Pre-op skin prep component ChloraPrep included within kits may allow the growth of Aspergillus penicillioides, which may penetrate the packaging resulting in a breach of the package integrity.

Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator.

Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator.

ChloraPrep applicators in the kit can grow organisms that can result in a breach of the applicators package integrity.

Provox Life Night HME may be incorrectly inserted sideways or forcefully through the adhesive coupling potentially occluding or blocking the stoma.

Randox can confirm a positive bias for Total Bilirubin and Direct Bilirubin of up to +15% across the assay ranges when using calibrator CAL2351, lot 1162UE. The positive bias has been attributed to bilirubin instability in the calibrator and is evident in both Quality Control (QC) and Patient samples.

Potential capacitor failure which typically manifests as in inability to provide output on one or more channels. In some instances, users reported a charring/smoky odor or emission.

Examination data and patient name may be mixed up when printing or generating a pdf with the interface at Pacific Coast and Laser Institute (PCLI).

Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator.

AquaBplus HF module on the AquaBplus 2500 osmosis system, an error in the US Installation Guideline instructed that 3-ring mains, instead of 2-ring mains, may be installed in combination with an AquaBplus 2500 device. The 3-ring main and fluid fly loops the heat disinfection may not be as effective as a 2-ring main installation

Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator.

Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator.

Firm received increased number of reports that VenaSeal dispensing systems are not effectively advancing the adhesive forward through the delivery catheter.