September 25, 2024Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls System Name: 722059 Allura Xper FD20/15 OR Table 722058 Allura Xper FD20/15 722039 Allura Xper FD20/20 OR Table 722038 A
Hazard: Potential Detachment of the Cable Hose Carrier (due to broken plastic and/or bolts) which May Result in Parts Falling and/or Part of the Cable Hose Dropping, and result in injury.
September 25, 2024Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls System Code Name: 722282 Azurion 7 M20 722281 Azurion 5 M20 722236 Azurion 7 B20 722235 Azurion 7 B12 722234 Azurion 7 M
Hazard: Potential Detachment of the Cable Hose Carrier (due to broken plastic and/or bolts) which May Result in Parts Falling and/or Part of the Cable Hose Dropping, and result in injury.
September 25, 2024Medical DevicesFDA
UNIMAX MEDICAL SYSTEMS INC recalls 1. Tech Medical Services Inc. Detachable Endo Retrieval Pouch, REF TM2001, 3" x 6", sterile; 2. Tech Medical Service
Hazard: The tube may fall into the surgical site during the grasping process.
September 25, 2024Medical DevicesFDA
Innovasis, Inc recalls TxHA PEEK IBF/TxTiHA IBF System REF BTA-151 i. TxHA The Innovasis TxHA PEEK IBF System is an intervertebral body fu
Hazard: Due to interfacing issues between the implant trial and inserter of the lumbar intervertebral fusion device.
September 25, 2024Medical DevicesFDA
Btt Health Gmbh recalls Marodyne-LiV, part number 3045-133, Low intensity vibration exerciser supporting osteoporosis treatment
Hazard: Some power supply units in Austria and Germany had a voltage drop in the millisecond range, which led to a cancellation of the treatment and subsequent restart of the medical device. The treatment is only restarted by a step-off/step-on (step-on for activation).
September 25, 2024Medical DevicesFDA
Carbon Medical Technologies, Inc. recalls BiomarC EX Fiducial Marker System, Catalog Number 040165
Hazard: This recall has been initiated due to a failure to provide an MRI Insert that is to be provided to the patient.
September 25, 2024Medical DevicesFDA
GE Healthcare recalls GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: a) 2110344-008; b) 2110344-009;
Hazard: Footprint Client (ZFP) versions v6.0 SP9.x and SP10.x where the latest addended report is not shown by default to the user. The issue occurs when the addendum is created on the same day as the original report but at a different time, and only when launched on the following browsers. " Internet Explorer 10 (IE10) " Internet Explorer 11 (IE11) " Firefox.
September 25, 2024Medical DevicesFDA
ROi CPS LLC recalls regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009
Hazard: Medical convenience kits were distributed with Merit syringes (manufactured by Jiangsu Shenli Medical Production) which were subsequently recalled.
September 25, 2024Medical DevicesFDA
MICROVENTION INC. recalls ERIC Retrieval Device REF: ER173020 ER174030 ER176044 The ERIC Retrieval Device is a mechanical thrombectomy devi
Hazard: Due to Retrieval Device product labels stating the incorrect expiration dates that (5 years instead of 3 years) which extends beyond their true expiration date.
September 25, 2024Medical DevicesFDA
Mazor Robotics Ltd recalls Mazor X. Model Number REF TPL0059; stereotaxic orthopedic instrument
Hazard: Software anomalies which can result in two separate issues: A lagging screen display during a navigated procedure; or the potential for a mismatch between the navigated screw and the screw information presented on the screen.
September 25, 2024Medical DevicesFDA
Tornier, Inc recalls stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS US Anatomic Nucleus, REF DWM003A; anatomic total arthroplasty of the s
Hazard: One lot of Perform Humeral Nucleus may exceed the specification for bacterial endotoxin load (max 20 EU/device).
September 25, 2024Medical DevicesFDA
Cypress Medical Products LLC recalls General Purpose Syringe McKesson 60 mL Luer Lock Tip Without Safety, Catalog Number 869662, McKesson Brand Catalog Numbe
Hazard: The syringes that were inadvertently shipped from the Distribution Center. This product was on quarantine because FDA has stated that these syringes lack FDA clearance and were inadvertently shipped due to an internal order processing error.
September 25, 2024Medical DevicesFDA
Medtronic Inc. recalls 2090 Programmers with serial number prefixes PKK0 and PKK1: a) 2090, Product Description: PRGM 2090 PROGRAMMER-PORT
Hazard: Medtronic CareLink 2090 programmers with serial number prefixes PKK0 and PKK1 have the potential for autonomous cursor motion when Finger Touchscreen capability is enabled by software version 3.2 or higher.
September 25, 2024Medical DevicesFDA
Boston Scientific Corporation recalls VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the uri
Hazard: There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.
September 25, 2024Medical DevicesFDA
Boston Scientific Corporation recalls vanSonnenberg Sump Locking Pigtail Regular Kit Sump Catheter System Kit, Material Number REF M001273090; for use as a pe
Hazard: There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.
September 25, 2024Medical DevicesFDA
Boston Scientific Corporation recalls Flexima Regular Kit Nephrostomy Catheter System Kit, Material Numbers REF M001271860; To provide external drainage of th
Hazard: There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.
September 25, 2024Medical DevicesFDA
Boston Scientific Corporation recalls Flexima Regular Kit Biliary Catheter System Kit, Material Numbers REF M001271650; bile drainage catheter with locking pi
Hazard: There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.
September 25, 2024Medical DevicesFDA
Boston Scientific Corporation recalls Flexima APDL Drainage Catheter System and Kit, Material Numbers: a) REF M001271960, b) REF M001271970; all-purpose drai
Hazard: There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.
September 25, 2024Medical DevicesFDA
GE Healthcare GmbH recalls ViewPoint 6, Model Numbers: a) H47581RJ, b) H47591MA, c) H47591MT, d) H47591PE, e) H47591PR, f) H47591RA, g) H47591SD,
Hazard: The National Institute of Standards and Technology (NIST) has identified in the National Vulnerability Database (NVD) that NexGen Healthcare Mirth Connect, prior to version 4.4.1, has a potential vulnerability allowing the deserialization of untrusted data (CVE-2023-43208). Mirth products may have been installed and configured with your ViewPoint / ViewPoint 6 system by GE HealthCare. This vulnerability could allow a malicious actor to access the system and potentially manipulate patient data.
September 25, 2024Medical DevicesFDA
GE Healthcare GmbH recalls ViewPoint; system, imaging processing, radiological
Hazard: The National Institute of Standards and Technology (NIST) has identified in the National Vulnerability Database (NVD) that NexGen Healthcare Mirth Connect, prior to version 4.4.1, has a potential vulnerability allowing the deserialization of untrusted data (CVE-2023-43208). Mirth products may have been installed and configured with your ViewPoint / ViewPoint 6 system by GE HealthCare. This vulnerability could allow a malicious actor to access the system and potentially manipulate patient data.
September 25, 2024Medical DevicesFDA
B. Braun Medical, Inc. recalls AET36 ANESTH EXT SET - Anesthesia Extension Set - Normally Closed Dual Manifold, Four-way Stopcock, Model/Catalog Number
Hazard: Potential for product leakage from the Spin Lock Connector on the distal end of the device due to the migration of excess solvent during the assembly process.
September 25, 2024Medical DevicesFDA
SEER MEDICAL PTY LTD recalls Seer Home System is an ambulatory electroencephalograph (EEG) system intended for at-home use for extended EEG and video
Hazard: During CAPA investigations of sight production inconsistencies, it was highlighted that previous Electromagnetic Compatibility (EMC) assessments related to RF radiated emissions may not be reasonably equivalent to the current product due to design changes in the system. A new CAPA was opened to investigate the radiated emissions compliance issues. - Seer Home Systems distributed and retained in the field were not compliant with Electromagnetic Compatibility (EMC) testing according to IEC 60601-1-2 - Seer Home Systems, including accessories, were manufactured and distributed without application of proper design change and manufacturing controls - Seer Home Systems were distributed with labeling deficiencies
September 25, 2024Medical DevicesFDA
CareFusion 303, Inc. recalls Alaris Pump Module Model 8100, a modular infusion pump and monitoring system
Hazard: Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring.
September 25, 2024Medical DevicesFDA
CareFusion 303, Inc. recalls Alaris Syringe Module Model 8110, a modular infusion pump and monitoring system
Hazard: Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring.
September 25, 2024Medical DevicesFDA
CareFusion 303, Inc. recalls Alaris EtCO2 Module Model 8300, a modular infusion pump and monitoring system
Hazard: Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring.
September 25, 2024Medical DevicesFDA
CareFusion 303, Inc. recalls Alaris PCA Module Model 8120, a modular infusion pump and monitoring system
Hazard: Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring.
September 25, 2024Medical DevicesFDA
CareFusion 303, Inc. recalls Alaris System PC Unit Model 8015 - a modular infusion pump and monitoring system
Hazard: Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring.
September 25, 2024Medical DevicesFDA
Baxter Healthcare Corporation recalls Baxter EXACTAMIX Inlet, Vented, Syringe Inlet, REF H938176, for use in a pharmaceutical compounding device
Hazard: Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets (disposable inlet), Product Codes H938173, H938174, H938175, H938176, used with the ExactaMix and ExactaMix Pro compounders. Particulate matter has been observed within the inlet primary packaging inlet components, including within the sterile fluid path tubing, before use.
September 25, 2024Medical DevicesFDA
Baxter Healthcare Corporation recalls Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175, for use in a pharmaceutical compounding device
Hazard: Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets (disposable inlet), Product Codes H938173, H938174, H938175, H938176, used with the ExactaMix and ExactaMix Pro compounders. Particulate matter has been observed within the inlet primary packaging inlet components, including within the sterile fluid path tubing, before use.
September 25, 2024Medical DevicesFDA
Baxter Healthcare Corporation recalls Baxter EXACTAMIX Inlet, Vented, High Volume Inlet, REF H938174, for use in a pharmaceutical compounding device
Hazard: Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets (disposable inlet), Product Codes H938173, H938174, H938175, H938176, used with the ExactaMix and ExactaMix Pro compounders. Particulate matter has been observed within the inlet primary packaging inlet components, including within the sterile fluid path tubing, before use.