493 alerts recorded, refreshed every six hours. Filter by source or category.
Shanghai United Imaging Healthcare is recalling its Computed Tomography X-ray System, Model uCT 760 with software. A software problem can hide patient images when certain functions are used, possibly requiring rescans for patients. Consumers should contact their imaging facility or the manufacturer for guidance.
Shanghai United Imaging Healthcare Co., Ltd. is recalling its Positron Emission Tomography and Computed Tomography System, model uMI Panorama GS with software. A software problem can prevent patient images from appearing on the Patient Administration interface, which may require rescans for patients scanned nationwide. Consumers should contact the facility where they were scanned to ask whether a rescan is needed.
The recall affects the Olympus Tripp-Lite P580-025 25ft DisplayPort Cable, model P580-025, an accessory for the OLYSENSE Hub System. The cable may cause video dropout or blackout in high-power mode, affecting users of the system. Consumers should stop using the cable and contact Olympus for further instructions.
ASP Global, LLC is recalling MPR Single Use Tourniquet Cuff 44" 1 Line (model DT-7044-01Q). The cuffs are labeled with a 10-year shelf life but only have a validated 5-year shelf life, exposing patients to risk if used beyond that period. Consumers should stop using affected cuffs and contact ASP Global for replacement or instructions.
ASP Global, LLC is recalling the MPR brand Single Use Tourniquet Cuff 15" 2 Line, model DT-7115-02Q. The cuffs, made between September 2016 and March 2023, carry an incorrect 10-year expiration date instead of the validated 5-year shelf life, exposing surgical patients to potentially expired sterile devices. Consumers should check the expiration date and stop using any affected cuff that is beyond the 5-year validated shelf life.
Wright Medical Technology's CHARLOTTE CLAW Screw, REF 40122716, for the CLAW II Polyaxial Compression Plating System is recalled. The screwheads have missing threads, preventing secure plate engagement, which may prolong surgery or require an alternative method. Consumers should contact their healthcare provider to determine if they have the affected screw and what to do.
Shanghai United Imaging Healthcare Co., Ltd. is recalling its Positron Emission Tomography and Computed Tomography System, model uMI Panvivo with software. A software problem prevents patient images from appearing on the Patient Administration interface when Split or Local function is enabled and multiple RIS exams are merged, which may require rescans for patients. The firm initiated a voluntary recall of the affected systems.
ASP Global's Disposable Tourniquet Cuff, 30" x 4" 2-Line, White, model ASP-564011, is affected. The cuffs have an incorrect expiration date, showing a 10-year shelf life instead of the validated 5 years, exposing surgical patients to potentially expired sterile devices. Consumers should check the manufacture date and stop using any cuff older than five years.
Cardinal Health 200, LLC is recalling Presource Packs containing Stryker StrykeFlow PS and AHTO tube sets, catalog number PB63VHSTC. The handpieces may leak fluid that pools on the floor, posing a slip and fall hazard to users. Consumers should stop using the affected kits and contact Cardinal Health for further instructions.
ASP Global is recalling its Disposable Tourniquet Cuff, 18" x 4" 1-Line, Red, model ASP-564006. The cuffs have an incorrect expiration date, showing a 10-year shelf life instead of the validated 5 years, which may affect sterility and patient safety during surgery. Consumers should stop using affected cuffs, check the manufacture date, and return or dispose of any product older than five years.
Expressaire disposable tourniquet cuffs, model A70107000, are affected. The cuffs show an incorrect expiration date, claiming a 10-year shelf life instead of the validated 5 years, exposing surgical patients to potentially unsafe use. Consumers should stop using these cuffs and contact ASP Global for instructions.
Philips is recalling its Ingenia Ambition S and Ingenia Ambition X MRI systems. The systems may export incorrect diffusion data in DTI scans, which can lead to wrong brain tractography results for patients when used with third-party software. Users should stop using affected software versions and contact Philips for instructions.
ASP Global, LLC is recalling its Expressaire Disposable Tourniquet Cuff, 12" x 3.5" 2-Line (CS 10) Plum, model 564003. The cuffs are labeled with a 10-year shelf life instead of the validated 5 years, exposing surgical patients to potentially ineffective or non-sterile devices. Consumers should stop using affected cuffs, check expiration dates, and return them to ASP Global.
ASP Global is recalling Expressaire Disposable Tourniquet Cuffs, model A70107004, a sterile cuff used during surgery. The cuffs have an incorrect expiration date, showing a 10-year shelf life instead of the validated 5 years, which could affect patients during surgical procedures. Consumers should stop using affected cuffs and contact ASP Global for replacement or return.
ASP Global is recalling its Expressaire Disposable Tourniquet Cuff, model 564005, a sterile cuff used during surgery. The cuffs have an incorrect expiration date, showing a 10-year shelf life instead of the validated 5 years, which could affect patients during surgical use. Users should stop using affected cuffs and contact ASP Global for replacement or return.
Philips is recalling its Ingenia Blue Seal SE and Blue Seal XE MRI systems, model numbers 782185 and 782192, with software versions R11, R12, and R13. The affected systems export diffusion tensor imaging scans with incorrect diffusion directions, which can cause third-party tractography software to misprocess brain nerve mapping, exposing patients to potentially inaccurate results. Users should contact Philips to arrange for a software correction or follow the recall instructions.
Shanghai United Imaging Healthcare Co., Ltd. is recalling its Computed Tomography X-ray System, Model uCT ATLAS Astound with software. A software problem can hide patient images on the Patient Administration interface, possibly requiring rescans for patients. The voluntary, firm-initiated recall means patients should contact their imaging facility for guidance.
Heraeus Medical GmbH is recalling PALACOS MV+G pro 40 and pro 80 bone cement kits, models 5081290 and 5081291. The cement may leak monomer liquid, exposing patients and healthcare workers to potential harm. Consumers should stop using affected kits and contact Heraeus Medical for instructions.
ASP Global's Expressaire Disposable Tourniquet Cuff, model 564013, is recalled. The cuff has an incorrect expiration date, showing a 10-year shelf life instead of the validated 5 years, exposing surgical patients to potentially expired sterile devices. Consumers should stop using the recalled cuffs and contact ASP Global for return or replacement.
Fisher Scientific, Henry Schein, Alere, Cardinal Health, Medline, and Pro Advantage urine pregnancy tests are affected. The tests may detect low hCG levels and give false positive results, affecting people who use them. Consumers should stop using the recalled tests and contact the manufacturer for instructions.
Philips North America is recalling SmartPath to MR 7700 systems with model numbers 782178 and 782207 and software versions R11, R12, and R13. The affected software exports diffusion tensor imaging scans with incorrect diffusion directions, which can cause third-party tractography software to misprocess brain fiber pathway data. Users should stop using the affected software for Enhanced MR DICOM exports and contact Philips for a correction.
Philips MR 5300 systems with model numbers 782110, 782152, 782156, or 782196 and software versions R11, R12, or R13 are affected. The hazard is that DTI scan exports contain incorrect diffusion directions, so third-party tractography software cannot correctly reconstruct brain nerve pathways, affecting patients whose scans are analyzed this way. Users must contact Philips for instructions on correcting the software.
Data comes from official CPSC and FDA publications (United States). Summaries are generated automatically from those publications: the cited source prevails.