ES1827KN SPINAL/EPIDURAL TRAY NRFIT Catalog # 339115
B. Braun Medical
Class I - Dangerous
The filter capacity is not achieved due to damage of the filter membrane.
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Other Medical Devices
🏥 Medical Devices • 15,809 recalls
SOMATOM go.Top; Models #11061640 Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data
Siemens Medical Solutions USA
Class I - Dangerous
The injector holder could potentially fall off together with the injector and the storage box.
SOMATOM go.Top; Models #11061648 Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data
Siemens Medical Solutions USA
Class I - Dangerous
The injector holder could potentially fall off together with the injector and the storage box.
Depth Electrodes, Foramen Ovale Depth Electrodes, Macro Micro Depth Electrodes, Spencer Probe Depth Electrodes, Wyler Sphenoidal Depth Electrodes
Ad-Tech Medical Instrument
Class I - Dangerous
Supplemental information provided with devices indicates that the subdural electrodes, depth electrodes, and anchor bolts are approved for use in the MR environment, for which they are not approved for such use.
Roche Elecsys Anti-CCP Immunoassay Catalog # 05031656160
Roche Diagnostics Operations
Class I - Dangerous
Performance issues with certain lots of the Elecsys Anti-CCP assay on the cobas e 411 analyzer; MODULAR ANALYTICS E 170 module; and cobas e 601, 602, and 801 modules with plasma samples.
SOMATOM go.Now; Models #11061610 & 11061618 Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data
Siemens Medical Solutions USA
Class I - Dangerous
The injector holder could potentially fall off together with the injector and the storage box.
EXACTAMED Oral Dispensers, 5mL, AMBER: PHARMACY PACK, REF H9388505, x500 PHARMACY PACK, REF H9388105, x100 COST CONTAINMENT, REF H93884205, x1500
Baxter Healthcare
Class I - Dangerous
EXACTAMED 5 mL Oral Dispenser Pharmacy Packs may contain both 5 mL and 10 mL oral dispensers.
The firm updated the IFU in April 2019 to clarify that use of the TRANSWARMER Mattress with other heat producing devices, such as an incubator, is prohibited and could lead to serious health consequences, such as skin burns. some products do not contain the updated IFU.
SOMATOM go.All; Models #11061638 Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data
Siemens Medical Solutions USA
Class I - Dangerous
The injector holder could potentially fall off together with the injector and the storage box.
FLEXIBLE NEURO-FIBERSCOPE, 3.7MM X 34CM, Model # 11282BN1
Karl Storz Endoscopy
Class I - Dangerous
The action is being initiated due to Flexible Neuroscopes manufactured with the incorrect channel port.
SOMATOM go.Up; Models #11061620 Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data
Siemens Medical Solutions USA
Class I - Dangerous
The injector holder could potentially fall off together with the injector and the storage box.
SOMATOM go.Up; Models ##11061628 Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data
Siemens Medical Solutions USA
Class I - Dangerous
The injector holder could potentially fall off together with the injector and the storage box.
Skull Anchor Bolts
Ad-Tech Medical Instrument
Class I - Dangerous
Supplemental information provided with devices may indicate that the subdural electrodes, depth electrodes, and anchor bolts are approved for use in the MR environment, for which they are not approved for such use.
SOMATOM go.All; Models #11061630 Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data
Siemens Medical Solutions USA
Class I - Dangerous
The injector holder could potentially fall off together with the injector and the storage box.
Class I - Dangerous
Monaco is displaying the Anatomy and Beam shift direction incorrectly on the Monaco Scan and Setup Reference Report and is DICOM exporting incorrect (Anatomy/Beam) shift directions.
EyeBOX Model OCL 02
OCULOGICA
Class I - Dangerous
A review of the user manual revealed that two precaution statements were missing.
Roche Elecsys Anti-CCP Immunoassay Catalog # 07251670190
Roche Diagnostics Operations
Class I - Dangerous
Performance issues with certain lots of the Elecsys Anti-CCP assay on the cobas e 411 analyzer; MODULAR ANALYTICS E 170 module; and cobas e 601, 602, and 801 modules with plasma samples.
Kit BD Max Enteric Viral Panel RUO; Catalog # 443715
Becton Dickinson &
Class I - Dangerous
The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.
Class I - Dangerous
Outflow Graft leaking at the pump connection during the implantation process. If the C-Ring is insufficiently seated, it renders the device nonfunctional because the Outflow Graft connection will leak during the implant procedure.
BD Vacutainer Lithium HeparinN (LH) 95 USP Units Blood Collection Tubes, Catalog Number 367886
Becton Dickinson & Company
Class I - Dangerous
False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples collected with tubes analyzed with the IL GEM 4000 instrument.