🏥 Medical Devices Class I - Dangerous
There is potential for the plastic optical tip to become detached from the metal shaft.
All Recalls
95,025 total recalls in our database
🏥 Medical Devices Class I - Dangerous
A manufacturing error resulted in out of specification R3 Acetabular Shells
Mazor X Surgical System Positioner Type II, REF: ASM0214-02
Medtronic Navigation
🏥 Medical Devices Class I - Dangerous
There is a potential for the surgical system to detach from the operational room table unexpectedly. This could result in the surgical system falling onto the patient resulting in blunt injury [hemorrhage, hematoma, bleeding, or fracture(s)]
🏥 Medical Devices Class I - Dangerous
potential risk that Legionella may be present in the Unity machine room, specifically the heat exchanger condensation collection tray.
🏥 Medical Devices Class I - Dangerous
Incorrect IOL diopter
STAINLESS STEEL REPROCESSING TRAY, 8MM ENDOSCOPE, IS4000, Model No. 400498-02 - Product Usage: is designed to enable complex surgery using a minimally invasive approach.
Intuitive Surgical
🏥 Medical Devices Class I - Dangerous
Small but detectable holes in the sterilization wrap used with the firm's 8 mm endoscope sterilization trays and handheld camera sterilization trays could lead to a potential breach of sterility and risk of infection. Certain features on the trays with handling and storage may cause these holes.
RayStation 6 Service Pack 2, UDI # 07350002010075 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
RAYSEARCH LABORATORIES AB
🏥 Medical Devices Class I - Dangerous
Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose.
🏥 Medical Devices Class I - Dangerous
Artis systems containing a Multi Display Manager of a specific lot, the power distributor may lead to an increased electrical contact resistance or the interruption of electrical contact, and result in planned procedures to be terminated and performed on an alternative x-ray system
🏥 Medical Devices Class I - Dangerous
There is potential for the plastic optical tip to become detached from the metal shaft.
BD FACS Sample Prep Assistant (SPA) II - Product Usage: K050191: The BD FACSCanto system with BD FACSCanto clinical software when used with the BD FACS Sample Prep Assistant II /III is intended for use as an in vitro diagnostic device for identification and enumeration of lymphocyte subsets in human cells in suspension using a lyse / no-wash sample preparation method for flow cytometry.
Becton, Dickinson and Company, BD Biosciences
🏥 Medical Devices Class I - Dangerous
The recalling firm confirmed that BD FACS Sample Prep Assistant (SPA) II and III users may encounter probes with unacceptable wear prior to reaching the 2500 piercings guideline indicated in the Instructions for Use (IFU). When the probe is worn, particles from the rubber cap are more likely to clog the probe, resulting in blocked or inadequate sample dispense.
RayStation 8A Service Pack 1, UDI # 07350002010136 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
RAYSEARCH LABORATORIES AB
🏥 Medical Devices Class I - Dangerous
Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose.
RayStation 5 Service Pack 3, UDI # 07350002010020 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
RAYSEARCH LABORATORIES AB
🏥 Medical Devices Class I - Dangerous
Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose.
🏥 Medical Devices Class I - Dangerous
Distributed to the field without having completed design history files or design transfer activities
🏥 Medical Devices Class I - Dangerous
A manufacturing error resulted in out of specification R3 Acetabular Shells
RayStation 6 Service Pack 3, UDI # 07350002010242 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
RAYSEARCH LABORATORIES AB
🏥 Medical Devices Class I - Dangerous
Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose.
Atellica CH Enzymatic Creatinine_2, Siemens Material Number 11097533, UDI Number 00630414595795 - Product Usage: use in the quantitative determination of creatinine in human serum, plasma, and urine for the diagnosis and treatment of renal disease.
Siemens Healthcare Diagnostics
🏥 Medical Devices Class I - Dangerous
The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples.
🏥 Medical Devices Class I - Dangerous
Distributed to the field without having completed design history files or design transfer activities
🏥 Medical Devices Class I - Dangerous
Philips has identified a Philips SureSigns VM1 monitor in the possession of a clinical user that was not intended for commercial distribution and for which Philips does not have records regarding its manufacture. Philips is therefore removing this device from distribution.
🏥 Medical Devices Class I - Dangerous
There is an increased risk of false positive Proteus results when using the Film Array Blood Culture Identification Panel (BCID) in vitro diagnostic test of blood cultures used in conjunction with specific media types. False positive Proteus results from this test may lead to patients receiving improper antibiotic treatment until culture results are available (within 24-48 hours).
🏥 Medical Devices Class I - Dangerous
A manufacturing error resulted in out of specification R3 Acetabular Shells