November 20, 2024Medical DevicesFDA
Draeger Medical, Inc. recalls Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Componen
Hazard: The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
November 20, 2024Medical DevicesFDA
Draeger Medical, Inc. recalls Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Component:
Hazard: The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
November 20, 2024Medical DevicesFDA
Boston Scientific Corporation recalls Boston Scientific SMARTFREEZE CRYO CONSOLE: Console: Material Number M004CRBS4000; CONSOLE REFURB: Material Number
Hazard: Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.
November 20, 2024Medical DevicesFDA
Boston Scientific Corporation recalls Boston Scientific POLARx FIT BALLOON CATHETER LT US, Material Number M004CRBS2160
Hazard: Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.
November 20, 2024Medical DevicesFDA
Boston Scientific Corporation recalls Boston Scientific POLARx FIT BALLOON CATHETER LT OUS, Material Number M004CRBS2110
Hazard: Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.
November 20, 2024Medical DevicesFDA
Boston Scientific Corporation recalls Boston Scientific POLARx FIT BALLOON CATHETER ST US, Material Number M004CRBS2060
Hazard: Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.
November 20, 2024Medical DevicesFDA
Boston Scientific Corporation recalls Boston Scientific POLARx FIT BALLOON CATHETER ST OUS, Material Number M004CRBS2010
Hazard: Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.
November 20, 2024Medical DevicesFDA
Boston Scientific Corporation recalls Boston Scientific POLARx BALLOON CATHETER LT 28MM OUS, Material Number M004CRBS2100
Hazard: Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.
November 20, 2024Medical DevicesFDA
Boston Scientific Corporation recalls Boston Scientific POLARx BALLOON CATHETER ST 28MM OUS, Material Number M004CRBS2000.
Hazard: Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.
November 20, 2024Medical DevicesFDA
Philips Respironics, Inc. recalls LifeVent EVO2. Model Number: SP2100X26B. Intended for invasive and non-invasive ventilation of pediatric through adult
Hazard: Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor, which could lead to inaccurate flow measurements.
November 20, 2024Medical DevicesFDA
Philips Respironics, Inc. recalls Garbin Evo. Model Number: LD2110X23B. Intended for invasive and non-invasive ventilation of pediatric through adult pa
Hazard: Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor, which could lead to inaccurate flow measurements.
November 20, 2024Medical DevicesFDA
Philips Respironics, Inc. recalls Aeris EVO. Model Number: VT2110X24B. Intended for invasive and non-invasive ventilation of pediatric through adult pat
Hazard: Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor, which could lead to inaccurate flow measurements.
November 20, 2024Medical DevicesFDA
Philips Respironics, Inc. recalls Trilogy EV300. Model Numbers: DS2200X11B, IN2200X15B, BL2200X15B, BR2200X18B, CA2200X12B, DE2200X13B, GB2200X15B, ND2200
Hazard: Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor, which could lead to inaccurate flow measurements.
November 20, 2024Medical DevicesFDA
Philips Respironics, Inc. recalls Trilogy Evo Universal Ventilator. Model Number DS2000X11B. Intended for invasive and non-invasive ventilation of pediat
Hazard: Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor, which could lead to inaccurate flow measurements.
November 20, 2024Medical DevicesFDA
Philips Respironics, Inc. recalls Trilogy Evo. Model Numbers: DS2110X11B, UDS2110X11B, RDS2110X11B, CA2110X12B, JP2110X16B, IN2110X15B, DE2110X13B, AU2110
Hazard: Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor, which could lead to inaccurate flow measurements.
November 20, 2024Medical DevicesFDA
Philips Respironics, Inc. recalls Trilogy Evo O2. Model Numbers: FP2100X10, DS2100X11B, IN2100X15B, DE2100X13B, IA2100X15B, EU2100X15B, LA2100X15B, EE2100
Hazard: Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor, which could lead to inaccurate flow measurements.
November 13, 2024Medical DevicesFDA
Smith & Nephew, Inc. recalls Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile, femo
Hazard: The Bipolar assembly contains an oversized Retainer Ring.
November 13, 2024Medical DevicesFDA
Baxter Healthcare Corporation recalls Hillrom Welch Allyn XScribe Cardiac Stress Testing System; Programmable Diagnostic Computer
Hazard: There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System (PACS)) relies solely on the UID to accept exams, this could lead to a mismatch of the patients identification with their physiological data.
November 13, 2024Medical DevicesFDA
Baxter Healthcare Corporation recalls Hillrom Welch Allyn Diagnostic Cardiology Suite (formerly Connex Cardio); Diagnostic spirometer
Hazard: There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System (PACS)) relies solely on the UID to accept exams, this could lead to a mismatch of the patients identification with their physiological data.
November 13, 2024Medical DevicesFDA
Baxter Healthcare Corporation recalls Hillrom Welch Allyn Vision Express Holter Analysis System; Electrocardiograph
Hazard: There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System (PACS)) relies solely on the UID to accept exams, this could lead to a mismatch of the patients identification with their physiological data.
November 13, 2024Medical DevicesFDA
Baxter Healthcare Corporation recalls Hillrom Welch Allyn RScribe 12-Lead Electrocardiograph System; Electrocardiograph
Hazard: There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System (PACS)) relies solely on the UID to accept exams, this could lead to a mismatch of the patients identification with their physiological data.
November 13, 2024Medical DevicesFDA
Baxter Healthcare Corporation recalls Hillrom Welch Allyn Q-Stress Cardiac Stress Testing System; cardiac stress test
Hazard: There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System (PACS)) relies solely on the UID to accept exams, this could lead to a mismatch of the patients identification with their physiological data.
November 13, 2024Medical DevicesFDA
Baxter Healthcare Corporation recalls Hillrom Welch Allyn HScribe Holter System; ambulatory monitoring
Hazard: There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System (PACS)) relies solely on the UID to accept exams, this could lead to a mismatch of the patients identification with their physiological data.
November 13, 2024Medical DevicesFDA
Ethicon, Inc. recalls Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Product Number J358H
Hazard: Complaints were received regarding needle pull-off and suture degradation. Analysis on returned product from this lot confirmed that some sutures were visually degraded in the package.
November 13, 2024Medical DevicesFDA
GE Healthcare recalls GE Healthcare Centricity Universal Viewer Zero Footprint, Model Numbers: 1) 2089507-083, GDZH-JINWAN-Centricity 2) 2
Hazard: GE HealthCare has become aware of an issue in Centricity Universal Viewer Zero Footprint Client (ZFP) where there is a potential security vulnerability which could allow a malicious actor to access the system and potentially manipulate patient data.
November 13, 2024Medical DevicesFDA
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION recalls The FLUOROspeed is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studie
Hazard: X-ray R/F system software with certain versions of the control board may occasionally fail to display images when switching from Fluoroscopy mode to Radiography mode, which may lead to the possibility of delay or cancellation of the examination.
November 13, 2024Medical DevicesFDA
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION recalls SONIALVISION G4 is a multi-purpose X-ray R/F system. The equipment is suitable for radiographic and fluoroscopic examina
Hazard: X-ray R/F system software with certain versions of the control board may occasionally fail to display images when switching from Fluoroscopy mode to Radiography mode, which may lead to the possibility of delay or cancellation of the examination.
November 13, 2024Medical DevicesFDA
Biocare Medical, LLC recalls intelliPATH Universal HRP Detection Kit, REF: IPK5011G80, containing DAB Buffer, Catalog Number: IPBF5009G20; ONCORE P
Hazard: Kits containing the DAB chromogen buffer, intended for use in either manual or automated Immunohistochemistry (IHC) staining protocols, may produce weak to no staining, which may lead to test failure requiring the test to be repeated.
November 13, 2024Medical DevicesFDA
Nihon Kohden America Inc recalls Adult Cap-ONE Biteblock REF YG-227T The cap-ONE Biteblock is intended to sample CO2 and administer supplemental oxyge
Hazard: Due to products being shipped/distributed to customers after the products expiration date had past.
November 13, 2024Medical DevicesFDA
Beckman Coulter, Inc. recalls The Access Cortisol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination o
Hazard: The Access Cortisol assay protocol file (APF) applies an incorrect calibration curve acceptance parameter at the S1 calibrator level that can lead to a high rate of calibration failures which can vary by reagent lot number. Calibration failure would lead to delay of measurement results reporting and potential injuries.