Medical Devices Recalls

Units not properly inspected prior to release to the market, may not function as indicated in the product labeling, resulting in syringe detection and infusion accuracy that can result in delays in therapy, overinfusion, or underinfusion.

Potential damage to the power cord may cause the power conductors to be exposed, thereby creating a risk of shock from the power mains.

In the Azurion system, the user can add a new study to a patient by selecting the option "Add Study". The Add Study dialogue box is then displayed where the Patient Type is selected to perform the study. Due to a software defect, when the study is initiated by pressing Start Procedure , the Patient Type changes inadvertently to a Patient Type different than the one selected as shown in the Table below. Patient type is one of the factors involved in the dose control process. The incorrect patient type changes the technique factors to be used by the system without notification to the user.

In 2018, Philips Respironics added foam replacement to the preventive maintenance schedule for these devices after discovering the polyester-based polyurethane (PE-PUR) foam may degrade into particles. This 2018 correction has been superseded by the device removal and rework described in Philips Respironics 2021 recall action for the same devices.

Instructions for Use (IFUs) updated to include use of a headband is now recommended for all patients and instructions for the application of the headband. Additionally, IFU updated to include warnings for risk of condensation build up depending on environmental conditions with instructions.

Sterility of device is compromised due to a sterile barrier breach

LYFO Disk Catalog #0983L is to contain Candida tropicalis. However, lot number 983-40-3 under Catalog #0983L, labeled as Candida tropicalis, is actually Yersinia entercolitica. This labeling error may cause a user's quality control to fail, resulting in testing needing to be repeated and delayed test results.

Sterility of device is compromised due to a sterile barrier breach

Due to partially assembled valved dressing that has a hole within it instead of the intended non-valved dressing in the package resulting in that the dressing cannot be centered over the open chest wound and create an occlusive seal due to the hole being present.

Sterility of device is compromised due to a sterile barrier breach

Sterility of device is compromised due to a sterile barrier breach

Distributed product did not undergo proper release testing.

Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language beyond the cleared 510(k) were inserted in the affected products. Firm is replacing these with the correct version of the IFU.

Sterility of device is compromised due to a sterile barrier breach

Sterility of device is compromised due to a sterile barrier breach

Sterility of device is compromised due to a sterile barrier breach

Due to lumbar puncture tray manometer failure mode of leaking and mating issues.

Due to lumbar puncture tray manometer failure mode of leaking and mating issues.

One ferrite ring expected to be installed on centrifugal pump system power cable may not be present.

Sterility of device is compromised due to a sterile barrier breach