Medical Devices Recalls

Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative pump is located. If the leak goes undetected it may result in a reduced level of drug delivery to the patient and consequently a lower level of pain relief than that prescribed or expected. This may result in the need for other, additional analgesic drug administration.

There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

Update to the carryover avoidance technical bulletin to introduce additional steps for reagent carryover avoidance with the Calcium assay on RX instruments. Carryover to the Calcium reagent results may result in falsely elevated or decreased results to both patient and QC samples.

There is a potential for an electrical short circuit to develop in a subset of 479 Model 26907 power supply cable plugs that connect to the Medtronic Model 29901 CareLink Encore programmer. A failure mode of the power supply has been found where an electrical short occurs on the low voltage direct current connector and results in the connector heating up, generating smoke, melting and in some cases disconnecting from the programmer.

The povidone iodine prep pads packaged with the arterial blood sampling kits will not maintain the iodine potency through its labeled 36-month expiration dating.

Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or nearby users.

Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or nearby users.

The povidone iodine prep pads packaged with the arterial blood sampling kits will not maintain the iodine potency through its labeled 36-month expiration dating.

Potential for the software on Automated PD System cyclers which can cause shortened dwell times during a Cycle-Based therapy

Two issues: Event 1: Normal operation of the device is to power up the device in the morning, register the first patient, and then perform a fluoroscopy. If, however, the user powers up the device in the morning and makes an error by starting a fluoroscopy while the first patient is still being registered, the device application will abnormally terminate and require service intervention before it can be used again. This event will not occur after the first patient procedure. Event 2: In rare cases a synchronization error may occur in the data transmission circuit in the device due to external noise. The visibility of the displayed image may be corrupted (images become bit-shifted abnormal images). If this event occurs, it may become difficult to see the object, which may hinder the examination and treatment.

The products were manufactured with longer than specified sheaths.

Potential for the software on Automated PD System cyclers which can cause shortened dwell times during a Cycle-Based therapy

The internal tip is missing from the device, causing the device to not function as intended.

A stability issue in the calibrators may cause calibration failures or atypical Quality Control results following a successful calibration.

False Positive ESBL Phenotype

A batch of 185cm Stingray Guidewires are incorrectly labeled as 300cm guidewires.

Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or nearby users.