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Showing 781–800 of 2956 results

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Proclaim DRG Pulse Generator (Abbott) – MRI Mode Malfunction (2023)

Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).

FDAJul 18, 2023Nationwide• Abbott Medical

Neodent Healing Abutment (Preat) – Dimensional Gap Risk (2023)

The healing abutments contain a dimensional condition that may lead to a gap between the healing abutment and the implant allowing for microleakage

FDAJul 18, 2023CA, FL, NJ +4 more• Preat Corp

ACUSON Redwood Ultrasound (Siemens) – Preset Compatibility Problem (2023)

If a user-generated preset for an 18L6 transducer created on a 1.0 ultrasound system is used with a 2.0 ultrasound system, the 2.0 ultrasound system will display underestimated measurement results when using an 18L6 transducer and viewing in the Dual format visualization function, which may lead to misdiagnosis of a patient's condition or influence patient management decisions in a negative way.

FDAJul 13, 2023Nationwide• Siemens Medical Solutions USA, Inc.

The following Pro.specta Emission Computed Tomography Sys... (Siemens Medical Solutions USA, Inc.) – during a whole-body planar scan with ... (2023)

During a whole-body planar scan with auto-contour, there is a possibility the short-linear drive (SLD) look-ahead sensors may trigger earlier than expected and may result in detector 1 positioning further from the patient than needed leading to a reduction in image resolution.

FDAJul 12, 2023ID, KS, MA +4 more• Siemens Medical Solutions USA, Inc.

LIF AMP, Adjustable Awl, REF 117-165, Part of the AMP Sys... (Alphatec Spine, Inc. 1950 Camino Vida Roble) – awl instrument adjustable drill butto... (2023)

Awl instrument adjustable drill button assembly assembled in the incorrect orientation, preventing locking feature from engaging with shaft at the desired set point; instruments lack ability to control awl depth by means of adjustable shaft advancement stop, which may lead to over insertion, dural tear, vascular/neurologic injury, adjacent tissue damage, increased operative time, revision surgery.

FDAJul 7, 2023Nationwide• Alphatec Spine, Inc. 1950 Camino Vida Roble

MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis ... – catheter center lumen was found to ha... (2023)

Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, partially or fully, and/or uncured or excessive MDX may dislodge from the catheter lead to full catheter obstruction resulting in delay to treatment and partial obstruction resulting in reduced flow, or particulate dislodgement that may result in delay to treatment, hemolysis, embolism/embolus or thrombosis/thrombus

FDAJun 28, 2023Nationwide

MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 20 c... – catheter center lumen was found to ha... (2023)

Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, partially or fully, and/or uncured or excessive MDX may dislodge from the catheter lead to full catheter obstruction resulting in delay to treatment and partial obstruction resulting in reduced flow, or particulate dislodgement that may result in delay to treatment, hemolysis, embolism/embolus or thrombosis/thrombus

FDAJun 28, 2023Nationwide

ellacor System with Micro-Coring Technology-Indicated for... (Cytrellis Biosystems, Inc.) – potential failure of a bearing adhesi... (2023)

Potential failure of a bearing adhesive joint that can occur due to an assembly issue of the X/Y stage of the handpiece. If a broken glue bond were to occur, it could cause an overlap of cores, potentially leading to prolonged healing and irregularities in patient skin texture post-treatment, and/or scarring

FDAJun 23, 2023Nationwide• Cytrellis Biosystems, Inc.

Zinc Sulfate Monohydrate (Jost Chemical) – Lead contamination (2023)

Zinc Sulfate Monohydrate, USP may contain elevated levels of lead.

Class IIModerate

FDAJun 22, 2023Nationwide• Jost Chemical Co

Ringed DxI Reaction Vessels (Beckman Coulter) – System Compatibility (2023)

Beckman Coulter, Inc. is recalling Ringed DxI Reaction Vessels (RVs) as part of Unicel DxI Immunoassay System (600, 800 series). The reason for the recall is that the firm has identified 3 lots of RVs that failed an internally used service test to evaluate washing efficiency. Increased relative light units (RLU) suspected to be caused by the resulting rough interior surface may lead to artificially falsely elevated results for susceptible tests, in particular, sandwich assays including, but not limited to, hsTnI, Hybritech p2PSA, IPTH/IPTH IO.

FDAJun 20, 2023Nationwide• Beckman Coulter, Inc.

Suction Coagulators (Megadyne) – Fluid Ingress Potential (2023)

An issue with the Suction Coagulator product family may lead to fluid ingress into the handpiece. Fluid ingress can lead to intermittent device activation, non-activation, or self-activation when plugged into the electrosurgery unit (ESU).

FDAJun 15, 2023Nationwide• Megadyne Medical Products, Inc.

RX Series Urea Enzymatic Assay (Randox) – Carryover Bias (2023)

Carryover from the Direct LDL-cholesterol assay on the Rx instruments may result in a negative bias, up to -11%, in quality control and patient samples, in urea assays results if the urea assay is run immediately after the Direct LDL-cholesterol assay. This may lead to a delay in reporting results or in falsely decreased urea test results.

FDAJun 13, 2023Nationwide• Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland

da Vinci Grasper (Intuitive Surgical) – Grip Breakage Risk (2023)

Fenestrated Graspers have a manufacturing issue has the potential to cause breakage on both upper and/or lower grips, which could lead to stainless steel fragments falling into the patient that may be either detected or undetected.

FDAJun 12, 2023Nationwide• Intuitive Surgical, Inc.

OmniTom X-ray CT System (NeuroLogica) – Device Mobility Risks (2023)

1. Wheels loosening over time with use of the device could lead to the inability to effectively drive the device and could lead to delay in patient treatment. 2.Batteries used to power the NL5000 device contain contaminated boards, which may impact the ability to power on the device, this could lead to delay for patient treatment

FDAJun 6, 2023Nationwide• NeuroLogica Corporation

Cardiosave Rescue IABP (Datascope) – Power Board Failure (2023)

An unexpected shutdown of the IABP may occur due to failures of tantalum capacitors in the Power Management Board and/or Solenoid Board. This issue may lead to an unexpected interruption of therapy.

FDAJun 5, 2023Nationwide• Datascope Corp.

Cardiosave Hybrid IABP (Datascope) – Power Board Failure (2023)

An unexpected shutdown of the IABP may occur due to failures of tantalum capacitors in the Power Management Board and/or Solenoid Board. This issue may lead to an unexpected interruption of therapy.

FDAJun 5, 2023Nationwide• Datascope Corp.

Cytosponge Cell Collection Device (Covidien) – Sponge Detachment Risk (2023)

Cell Collection Device may be at increased risk of the sponge detaching from the string during removal of the device from the patient, which could lead to device fragments in patient, obstruction, airway obstruction, secondary intervention, secondary intervention (with the primary procedure), supraglottic airway obstruction, and aspiration.

FDAJun 2, 2023Nationwide• Covidien, LLC

DxA Automation System (Beckman Coulter) – Test Sample Compatibility (2023)

A software defect in the DxA Automation System may cause tests to be run on patient samples in tube types not compatible with the requested test, leading to erroneous patient results

FDAJun 2, 2023AL, CA, FL +16 more• Beckman Coulter Biomedical GmbH Sauerbruchstr. 50 Munchen Germany

UFSK Treatment Chair 500 XLE (UFSK) – Drive Mechanism Wear (2023)

Service life of the electrical seat part drive of the treatment chair may be shortened unexpectedly after several years of use due to a potential wear-related reduction in the self-locking of the drive and may remain undetected. A worsened self-locking of the seat drive can lead to overriding the drive s end position when positioning the patient with the seat part in an inclined position

FDAMay 31, 2023Nationwide• UFSK International OSYS Gmbh Kirchhoffstr. 1 Ratisbon Germany

Alinity ci-series Control Module (Abbott) – System Performance Issues (2023)

There are potential performance issues found in the Alinity ci-series System software versions 3.4.0 and lower, including: 1) SCC Reagent load error during daily maintenance; 2) Sample Laboratory Report error; 3) Customer requests mechanism to prevent user error when creating new lots of value assigned Calibrators; 4) Error in processing tests after CCCintController encountered an error with the assay information downloaded from SCC; 5) The assay editor does not correctly check sample dilution total volume limits; 6) User-Applied Labels not adhering to Reagent Bottles; 7) ICT Module did not expire after warranty was exceeded. These performance issues could lead to erroneous results for multiple analytes.

FDAMay 30, 2023AL, AK, AZ +43 more• Abbott Laboratories

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