Medical device recalls

RayStation versions 17.0.0 and 17.0.1 have a software error that prevents dose calculations from updating properly when certain regions of interest are modified. This can occur when regions have no contours but include material overrides or are marked as Bolus, Fixation, or Support types. Users may not see updated radiation doses after making changes.

RayStation version 2024B has a software issue where calculated radiation doses may not update correctly when certain regions of interest (ROIs) are modified. This affects ROIs without contours that have material overrides or are classified as Bolus, Fixation, or Support types. Clinics using this version should verify their dose calculations are accurate.

RayStation radiation therapy planning software versions 2024A SP1 and 2024A SP2 have a bug that prevents dose calculations from updating correctly when certain regions of interest (ROIs) are modified. This affects ROIs without contours that have material overrides or are classified as Bolus, Fixation, or Support types. If changes are made to these ROIs, the system may not recalculate doses as intended.

RaySearch's RayStation radiation therapy planning software version 10B SP1 has a flaw where calculated radiation doses may not update correctly when certain regions of interest are modified. This affects regions with no contours that have material overrides or are classified as Bolus, Fixation, or Support types. Clinical staff may unknowingly rely on outdated dose calculations.

RayStation radiation therapy treatment planning software (versions 14.0.0, 15.0.0, and 15.1.3) may not properly update calculated radiation doses when certain regions of interest are modified. This can occur when regions have no contours but have material overrides or are classified as bolus, fixation, or support types. Changes to these regions may not trigger the dose recalculation as intended.

RayStation versions 12A, 12A SP1, and 12A SP2 contain a software bug that prevents dose calculations from updating properly when certain regions are edited. This affects only specific region types (Bolus, Fixation, Support) with no contours that have material overrides. Users may not see updated radiation doses after making changes.

RaySearch RayStation/RayPlan radiation therapy planning software (versions 11B through 11B SPT1) has a bug that prevents dose calculations from updating correctly when changes are made to certain regions of interest with material overrides or specific geometry types. This could result in treatment plans using outdated radiation dose calculations.

RaySearch Laboratories identified a software bug in RayStation/RayPlan versions 11.0.0 through 11.0.4 (11A, 11A SP1, SP2, SP3) used for radiation therapy treatment planning. When certain regions of interest have no contours but have material overrides or are classified as Bolus, Fixation, or Support types, the software fails to recalculate radiation doses correctly if you modify or remove the material override. This could result in outdated or incorrect dose calculations being used for treatment planning.

RaySearch Laboratories' RayStation/RayPlan version 10B has a software issue that can prevent proper recalculation of radiation therapy doses when certain regions are modified. This affects specific treatment planning scenarios where regions have no contours but have material overrides or are classified as Bolus, Fixation, or Support types. Stale dose calculations may be used instead of updated ones.

Medline Industries has recalled certain Full Electric Low Lightweight Homecare Beds (model MDR107003LO) because the hand control pendant and its wires can overheat and catch fire in rare situations—such as when the bed is overloaded, blocked, or has jammed parts. The company has received 58 reports of the pendant sparking, burning, melting, smoking, or catching fire.

The hand control pendant on Medline Full Electric Lightweight Homecare Beds (model MDR107003L) can overheat and catch fire in rare cases, especially if the bed is overloaded, blocked, or has jammed parts. Medline has received 58 reports of the pendant sparking, burning, melting, or smoking.

Medline's Full Electric Low Basic Homecare Bed (model MDR107003ELO) has a hand control pendant that may overheat and catch fire in rare cases—such as when the bed is overloaded, blocked from moving, or has jammed parts. Medline has received 58 reports of the pendant sparking, burning, melting, smoking, or catching fire. No injuries have been reported.

Medline Industries is recalling certain Full Electric Basic Homecare Beds because the hand control pendant and cord may overheat and catch fire in rare situations—such as when the bed is overloaded, blocked, or has jammed parts. The company has received 58 reports of the pendant sparking, burning, melting, or smoking.

Medline's Semi Electric Lightweight Homecare Bed (model MDR107002L) has a potential fire hazard in the hand control pendant and wires. In rare cases—such as when the bed is overloaded, blocked, or jammed—the pendant may overheat and spark, burn, melt, or catch fire. Medline has received 58 complaints of pendant sparking, burning, melting, smoking, or fire.

Medline's semi-electric homecare beds have hand control pendants that may overheat and catch fire in rare cases—for example, if the bed is overloaded, blocked, or jammed. The company has received 58 reports of the pendant sparking, burning, melting, or smoking.

Certain batches of syringes in ICU Medical's Portex Spinal Tray may have cracks in the syringe collar. This defect can prevent the syringe from working properly, cause repeated blood draws, or lead to blood leakage during arterial blood sampling or fluid delivery.

ICU Medical Inc. is recalling specific lots of Pulsator Arterial Blood Sampling Kits because some syringes have cracks in the collar. This crack can cause blood to leak during sampling, delays in blood draws, or the need to repeat the procedure.

Thoratec CentriMag blood pump components used in acute circulatory support and ECMO systems may not lock securely into the motor. If the pump fails to lock properly, the system may not generate an alarm, which could delay critical heart support or cause serious complications.

Medtronic has recalled certain Abre Venous Self-Expanding Stents due to a manufacturing issue with the stent material (Nitinol) that can cause the stent to be smaller than intended when deployed. This reduced size may result in the stent moving out of position after placement.

Intuitive Surgical is recalling certain da Vinci SP Access Port Kits because the sterile trays may develop cracks during storage or handling. A cracked tray could allow bacteria or other contaminants to enter, compromising the sterile field during surgery. No injuries have been reported.

Instrumentation Laboratory has recalled a coagulation test reagent (Part Number 0020006800, Lot N1136730) used to evaluate blood clotting and monitor heparin therapy due to potential microbial contamination. The affected lot expires 12/31/2025 and was distributed worldwide including multiple U.S. states and countries. No injuries have been reported to date.

ICU Medical identified a batch of defective speakers in some Plum Duo Infusion Pumps that may fail silently. If the speaker fails, the pump will not produce audible alarms, alerts, or sound feedback when you touch the screen. This could delay recognition of important pump notifications.

Hologic's ThinPrep CytoLyt Solution (a buffered cell wash used in laboratory testing) from lot number 5062EC has been found to contain fungal contamination. The affected product was distributed nationwide. No injuries have been reported.

The Catalyst+ patient positioning system used in stereotactic radiosurgery (a type of radiation therapy) has a software issue that may cause incorrect patient positioning. In some cases, the system may show a patient is correctly positioned when they are actually outside the safe treatment area, which could affect treatment accuracy.

Philips Azurion X-ray imaging systems running software versions R2.1.10 or R2.2.10 may experience six different software problems. These include unexpected system restarts, continuous restart loops, storage space issues, and positioning errors that could affect image quality or system availability.

Medline medical procedure kits containing Stryker's Strykeflow 2 Suction Irrigators may leak irrigation fluid into the handpiece and battery pack during use due to a 2024 design change. Some devices have leaked fluid or released vaporized saline that may resemble smoke.

Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design change has caused some devices to leak and/or emit vaporized saline (which can resemble smoke) during use.

Medline medical procedure kits containing Stryker's Strykeflow 2 Suction Irrigators are being recalled due to a 2024 design change. The change allows irrigation solution to leak into the handpiece and battery pack during use, and some devices have emitted vaporized saline that resembles smoke. No injuries have been reported.

Medline medical procedure convenience kits containing Stryker's Strykeflow 2 Suction Irrigators have a design flaw that allows irrigation solution to leak into the handpiece and battery pack during use. Some devices have leaked fluid or emitted vaporized saline that may resemble smoke during procedures.

Medline medical procedure kits containing Stryker Strykeflow 2 Suction Irrigators may leak or emit vaporized saline during surgery due to a 2024 design change. The irrigation solution can travel into the handpiece and battery pack, potentially causing device malfunction or creating a smoke-like vapor in the surgical field.