Tecnología Médica
Tecnología Médica
Hemashield Gold Knitted Graft
02/02/2023 -
Product was identified as potentially non-sterile as it received an underdose of gamma irradiation during the sterilization process. As the sterilization dose was not achieved, the sterility...
FDA Roundup: January 31, 2023
01/02/2023 -
FDA Roundup: January 31, 2023
Medtronic Recalls Mahurkar Acute Dual Lumen High Flow Hemodialysis Catheters for Potential Catheter Hub Defect
31/01/2023 -
A catheter hub defect may cause the Mahurkar Acute Dual Lumen High Flow Catheter to leak across the catheter’s two tubes.
LivaNova (TandemLife) Adds to Recall for LifeSPARC System that May Experience Unintentional Extended Pump Stops Due to Controller Critical Failure
30/01/2023 -
The LifeSPARC System is being recalled because users can inadvertently cause extended pump stop. A software update will address this issue.
LivaNova (TandemLife) Adds Software Update to Recall for LifeSPARC System for Risk of Unintentional Extended Pump Stop During Controller Critical Failure
30/01/2023 -
The LifeSPARC System is being recalled because users can inadvertently cause extended pump stop. A software update will address this issue.
Nasal Septal Button, 5-Cm
27/01/2023 -
Summit Medical received a customer complaint that Nasal Septal Button, 5cm, SP-78105 parts received from lot# 219349 were in unsealed pouched. The product was sterilized, but if this sterile barrier...
Flowtriever Retrieval/Aspiration System
27/01/2023 -
There is a potential malfunction with the side-port of the Triever 24. The side-port may potentially leak or dislodge during device preparation or during actual use. The side-port of the triever24...
Beaver Edgeahead Stiletto/Mvr Knife 0.90mm Straight (20g)
27/01/2023 -
BVI has received a complaint from a customer that catalog # 376630 of the Beaver Edgehead Stiletto/Mvr knife 0.90 mm Straight (20g), a component of the Readpak kit (cat:584896, lots:6054175,6053035),...
La AEMPS actualiza la información del problema de seguridad de determinadas mascarillas con imanes de Philips Respironics
26/01/2023 -
La Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) publicó el 30 de septiembre de 2022 la
La AEMPS informa de varios fallos de software relacionados con las bombas de insulina t:slim X2
26/01/2023 -
La Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) ha tenido conocimiento, a través del fabricante Tandem Diabetes Care, Inc., Estados Unidos, de cuatro posibles...
Hickman And Leonard Lumen CV Catheters
26/01/2023 -
The catheter repair adhesive used to attach the repair segment to the original catheter is hardened/coagulated (unusable). Recall start date: January 4, 2023
Nuzone X2 Synthetic Polychloroprene Sterile Surgical Gloves Powder Free
26/01/2023 -
The recall is due to quality complaints from health care professionals that the gloves may not meet their intended use in a medical/surgical setting. The gloves easily tear and may result in...
Datascope/Getinge Recalls Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABP) for Risk That Blood May Enter Pump Through Damaged Balloon Catheter, Causing Patient Harm
26/01/2023 -
Blood may enter the Cardiosave IABP through a damaged balloon catheter, causing pump shut-down, or patient exposure to helium or cross-contaminated blood
2023 Medical Device Recalls
26/01/2023 -
2023 Medical Device Recalls
Cardinal Health™ Jackson-Pratt™ channel drains
26/01/2023 -
Cardinal Health has initiated a medical device correction for specific production lots of the Cardinal Health™ Jackson-Pratt™ channel drains. The recall is being issued due to various performance...
Statis Dental Handpieces
26/01/2023 -
The manufacturer of Statis SL handpieces has informed SciCan that the product may not function as expected if not properly maintained. When using the Statis handpieces, the lack of care or...
Novastar Full Face Mask
26/01/2023 -
In case the magnets of the Novastar TS and Novastar Plus are positioned near medical devices (implanted as well as not-implanted) and metallic implants the magnetic field might impact the implants or...
Novaguide Intelligent Ultrasound System
26/01/2023 -
Defective hard drives were identified in the graphical user interface tablet of some devices. The defective component leads to tablet screen freeze and reboot occurrences, eventually rendering the...
Visiusmatrix 4.0
26/01/2023 -
This recall is being initiated to address a potential risk associated with use of the Visiusmatrix 4.0 devices. We have identified that the hardware equipment racks of the Visiusmatrix 4.0 devices at...
Somatom X.Cite
26/01/2023 -
In the Syngo.ct va40 and Syngo.ct va50 myneedle guide application, the order of the orientation labels "head", "center", and "feet" in the axial thick slice segments...
