Medical device recalls

Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. In addition, the second line description on the titanium pin label mistakenly lists ceramic tip. The second line description should state titanium pin.

The software in the systems may not process the cycle originally intended. This could result in damage to the various medical devices and instruments processed in the washer/disinfector or potential for inadequate cleaning or disinfection.

The software in the systems may not process the cycle originally intended. This could result in damage to the various medical devices and instruments processed in the washer/disinfector or potential for inadequate cleaning or disinfection.

Five batches of the product have failed the specification of 1.0kPa for Burst Pressure.

Five batches of the product have failed the specification of 1.0kPa for Burst Pressure.

Imprecision in the affected lot may produce negatively or positively biased patient sample and quality control fluid results.

LINET has recently become aware of a potential safety issue for the AVE 2 Birthing Bed caused by the power cable breaking at the bed connection or the orange insulation of the power cable may fail causing a possible spark or possible exposure to a live conductor.

The products were manufactured without a back bevel on the needle tip. This could cause damage to the inside of the introducer during needle insertion.

The affected flat screen monitor holders might not be compliant with grounding requirements. As a consequence, there is a risk of mild to severe/fatal electric shock under certain conditions while using the flat screen monitor holder with voltage of 100-220V.

The affected flat screen monitor holders might not be compliant with grounding requirements. As a consequence, there is a risk of mild to severe/fatal electric shock under certain conditions while using the flat screen monitor holder with voltage of 100-220V.

The affected flat screen monitor holders might not be compliant with grounding requirements. As a consequence, there is a risk of mild to severe/fatal electric shock under certain conditions while using the flat screen monitor holder with voltage of 100-220V.

The affected flat screen monitor holders might not be compliant with grounding requirements. As a consequence, there is a risk of mild to severe/fatal electric shock under certain conditions while using the flat screen monitor holder with voltage of 100-220V.

The swivel arm holding the monitors may become dislodged from the carrying arm.

The swivel arm holding the monitors may become dislodged from the carrying arm.

Potential lack of carbon dioxide (CO2) flow that may result in a procedural delay during off-pump coronary artery bypass (OPCAB).

Cepheid Xpert Respiratory Control Panel (Catalog #8199) has an reduced expiration date from 24 months to 13 months.

False negative results with the BD MAX Extended Enteric Bacterial Panel when testing specifically for Enterotoxigenic Escherichia coli (ETEC) and Plesiomonas shigelloides targets of the BD MAX Extended Enteric Bacterial Panel assay.

The faceplates may incorrectly identify the T2 Basic Long Instrument Set as T2 Basic Short Instrument Set.

The firm is recalling their Delta family of patient monitors software due to cybersecurity vulnerabilities, which may cause the device to reboot, lose functionality, and/or lose communication.

The firm is recalling their Delta family of patient monitors software due to cybersecurity vulnerabilities, which may cause the device to reboot, lose functionality, and/or lose communication.

Affected lots of reprocessed arthroscopic shavers may display the incorrect catalog number and speed settings when connected to the generator, require manual mode for use on CORE generators, or display an error message on Crossfire 1 and 2 generators which does not allow the device to be used.

The product was potentially being packaged without a taper adapter.

Abbott internal testing has identified that the Magnesium urine application demonstrates depressed urine result recovery. All samples >0.5mEq/L fail the linearity acceptance criteria for the bias specification and demonstrate depressed recovery of up to 37%. The specific cause of the negative bias/depressed results is currently under investigation.

The Controller does not detect overpressure in the balloon during the application of non-dosing puffs of Nitrous Oxide, which can contribute to balloon over pressurization, if the intended vent lumen of the catheter is significantly occluded to prevent relieving balloon pressure due to a kinked catheter condition.If a patient is exposed to higher than physiologic pressures, adverse events such as perforation or mucosal laceration may occur.

During a post approval study the firm found there was an increased risk of corneal haze following the implantation of this device.

The product is contaminated with Pseudomonas.

There is a potential for difficulty in sliding down the retention mechanism on the sets manufactured with a specific extension spring lot.

There is a potential for difficulty in sliding down the retention mechanism on the sets manufactured with a specific extension spring lot.

Presence of natural rubber latex is not declared in the label

If Improve Target Dose was chosen as an optimization model in a previous treatment session, Monaco¿ will automatically use this optimization model again when proceeding with the online plan adaptation of a completion plan when it should not.