Medical device recalls

A systematic positive bias of up to 20% was identified across the reportable potassium range, resulting in false elevation results of patient samples when using Medica s capillary tubes.

The affected Estrone RIA kit lots may rarely give falsely high patient results which might cause Temporary injury of Remote probability. Only in some (very rare) cases may the issue occur.

Pumps were released without full testing being performed, including occlusion alarm testing.

Due to damage to outer tray that can potentially compromise the sterile barrier

Under circumstances involving exposure to particular chemicals and mechanical forces, the male luer connectors for the specified IV Administration and Extension sets may leak, crack, and/or break during use, which may result in a delay in patient treatment, blood loss, infection, an air embolism, and/or underdosage of medication.

Potential packaging failures, which could lead to a breach in the sterile barrier.

Potential packaging failures, which could lead to a breach in the sterile barrier.

Potential packaging failures, which could lead to a breach in the sterile barrier.

Due to product that may contain a void in the material that separates the wire guide and cutting wire lumens, which may cause an inappropriate path of current during cutting.

Issue with software algorithm which may lead to overpressure events.

Issue with software algorithm which may lead to overpressure events.

Issue with software algorithm which may lead to overpressure events.

This is a sub-recall of event RES 96885. The supplier identified that during their manufacturing process for a limited batch of MNA-6x0 (adapter) components the incorrect configuration file was used.

Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.

Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.

Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.

Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.

Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.

Robotic-assisted surgical system has Viewer Display manufactured with outdated firmware, may result in loss of one display-loss of 3D surgical field (depth perception) but 2D maintained, or loss of both displays-complete visualization loss, without fault, instruments remain active, could lead to instrument contact with tissue, resulting in injury/bleeding; may require alternate surgical modality.

Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.

Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.

Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.

Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.

Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.

Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.

Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.

Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.

Due a design issue where the navigated array connection geometry is incorrect.

Due a design issue where the navigated array connection geometry is incorrect.

units manufactured in a limited time period may emit electromagnetic noise beyond the acceptable limits for RTCA application specified in RTCA DO-160G Chapter 21, Equipment Category M.