Medical Devices Recalls
Defective surgical instruments, diagnostic equipment, and health device recalls.
MAVERICK¿ Measurement Module Spectrometer PN 820-01367 (originally part of a kit...
Potential Elevated Laser Output A disconnected cable or a poorly crimped cable under mechanical bending stress can cause loss of electrical contact. At one connection on the board, the failure can drive the laser output to approximately 1,600 mW. Potential Unintended Laser Firing A disconnected, or poorly crimped cable can falsely signal a fire command during measurement cycles. At a secondary location on the board, this fault can lead to unexpected laser activation during operation. Safety logic prevents firing when the system is idle.
Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G1210009...
Stents may be impacted by a Nitinol anomaly which causes a reduced stent diameter when deployed and corresponding reduced radial force. Issue may result in stent migration.
Medline Kits containing B. Braun IV Administration Sets and Pump Administration ...
Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.
VANTAGE GALAN 3T Model MRT-3020/MEXL-3020
There is a potential for formation of ice occurring in the venting system of the superconducting magnet of the MRI systems. if a quench occurs in this condition, helium gas may not be able to escape via the designed vent paths, and the pressure in the helium vessel may rise. This pressure build-up could eventually rupture the helium vessel, causing helium gas to be released into the MR scanning room.
Portex Spinal Tray, Item No. A3729-24 A3595
Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw/fluid delivery. This issue may also lead to blood leakage during sampling of arterial blood or leakage during fluid delivery.
Medline Kits containing B. Braun IV Administration Sets and Pump Administration ...
Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.
MOSAIQ Oncology Information System with Particle Therapy License (License Kit 4...
Using oncology information system that manages workflow may result in overtreatment if:Plan delivered with Particle Therapy IHE-RO TDW-II interface,With one field per fraction or last field partial treatment,Partial treatment occurs followed by treatment field interruptions with manually recorded partial treatment,Then treatment unit doesn't check meterset value so partial treatment delivered twice
FreeStyle Libre 3 Plus Sensor REF 72080-01 UDI-DI code: 00357599819002 The Free...
Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results
FreeStyle Libre 3 Plus Sensor REF 78768-01 UDI-DI code: 00357599844011 The Free...
Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results
FreeStyle Libre 3 Sensor REF 72081-01 UDI-DI code: 00357599818005 The FreeStyle...
Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results
Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.
Emphasizing instructions for LVP duration programming located in the IFU.
Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174
Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.
Allura Xper FD20/20; Model Number: 722038;
Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.
Medline Kits containing B. Braun IV Administration Sets and Pump Administration ...
Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.
SMV DSI, System, Tomography, Computed, Emission
GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as Impacted Systems and listed in the Affected Product Details section of this letter) could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury. There have been no reports of detector falls or injuries as a result of this potential issue. The Impacted Systems affected by this notice are those that have not been manufactured for several years. GE HealthCare has previously communicated End of Guaranteed Service for these Impacted Systems.
da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 (2....
Access Port System tray may develop cracks potentially resulting in a sterility breach.
Medline Kits containing B. Braun IV Administration Sets and Pump Administration ...
Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.
Medline medical procedure convenience kits labeled as: KIT ROBOTICS UROLOGY PRO...
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.
Allura Xper FD10/10; Model Number: 722027;
Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.
Medline Kits containing B. Braun IV Administration Sets and Pump Administration ...
Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.
Medline medical procedure convenience kits labeled as: 1) ROBOTIC, REF CDS980...
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.
Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 ...
Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw/fluid delivery. This issue may also lead to blood leakage during sampling of arterial blood or leakage during fluid delivery.
BD Pyxis ES Enterprise Server Catalog Numbers 1115-00, 137672-02,137672-03 1376...
Due a software issue that may result in equipment not receiving timely updates of patient, medication, or related information from enterprise systems.
The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with s...
Issues identified: 1) Results vary by Instrument Platform; 2) Calibrator Lot-to-Lot Variability. Issues may lead to delayed or incorrect diagnosis, as well as delay of treatment or incorrect treatment.