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Showing 2661–2680 of 8389 results

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Flexima APDL Drainage Catheter System and Kit, Material N... (Boston Scientific Corporation) – there is the potential for holes in t... (2024)

There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.

FDAJul 18, 2024Nationwide• Boston Scientific Corporation

Flexima Regular Kit Nephrostomy Catheter System Kit, Mate... (Boston Scientific Corporation) – there is the potential for holes in t... (2024)

There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.

FDAJul 18, 2024Nationwide• Boston Scientific Corporation

Mazor X. Model Number REF TPL0059; stereotaxic orthopedic... – software anomalies which can result i... (2024)

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.

Moderate

FDAJul 17, 2024Nationwide

Power Express, REF B90918 (Beckman Coulter Biomedical GmbH Sauerbruchstr. 50 Munchen Germany) – metal contamination (2024)

The adhesive joint between the plastic socket and metal component of the Power Express Sample Holder can fail, causing the metal part to detach and enter the centrifuge. This detachment can result in damage to the centrifuge and potential destruction of the patient sample resulting in delayed results and possible exposure of lab technician to biohazardous material.

FDAJul 17, 2024Nationwide• Beckman Coulter Biomedical GmbH Sauerbruchstr. 50 Munchen Germany

PE Centrifuge Temperature Controlled, REF: B36366, a comp... (Beckman Coulter Biomedical GmbH Sauerbruchstr. 50 Munchen Germany) – metal contamination (2024)

The adhesive joint between the plastic socket and metal component of the Power Express Sample Holder can fail, causing the metal part to detach and enter the centrifuge. This detachment can result in damage to the centrifuge and potential destruction of the patient sample resulting in delayed results and possible exposure of lab technician to biohazardous material.

FDAJul 17, 2024Nationwide• Beckman Coulter Biomedical GmbH Sauerbruchstr. 50 Munchen Germany

WAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC... (Boston Scientific Neuromodulation Corporation) – spinal cord stimulation (scs) implant... (2024)

Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) may experience routine system check during IPG charging, which may cause device reset, which may lead to transient loss of stimulation; patients may experience undesired sensations when therapy turns off for approx. 10-15 seconds and then back on, which may lead patient to request surgical intervention for replacement or revision.

FDAJul 17, 2024Nationwide• Boston Scientific Neuromodulation Corporation

PE Centrifuge, REF: B36365, a component of the Power Express (Beckman Coulter Biomedical GmbH Sauerbruchstr. 50 Munchen Germany) – metal contamination (2024)

The adhesive joint between the plastic socket and metal component of the Power Express Sample Holder can fail, causing the metal part to detach and enter the centrifuge. This detachment can result in damage to the centrifuge and potential destruction of the patient sample resulting in delayed results and possible exposure of lab technician to biohazardous material.

FDAJul 17, 2024Nationwide• Beckman Coulter Biomedical GmbH Sauerbruchstr. 50 Munchen Germany

Spectrum Wireless Battery Modules A/B/G/N, (Baxter Healthcare Corporation) – the spectrum wbm may fail to auto-doc... (2024)

The Spectrum WBM may fail to auto-document infusion status information back to the hospital's Electronic Medical Record (EMR) system. This software issue only impacts customers where the Spectrum V8 or Spectrum IQ infusion system is integrated with the hospital s EMR system.

FDAJul 17, 2024Nationwide• Baxter Healthcare Corporation

Baxter Spectrum Wireless Battery Modules A/B/G/N, (Baxter Healthcare Corporation) – the spectrum wbm may fail to auto-doc... (2024)

The Spectrum WBM may fail to auto-document infusion status information back to the hospital's Electronic Medical Record (EMR) system. This software issue only impacts customers where the Spectrum V8 or Spectrum IQ infusion system is integrated with the hospital s EMR system.

FDAJul 17, 2024Nationwide• Baxter Healthcare Corporation

Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls... (Beckman Coulter, Inc.) – beckman coulter has become aware of a... (2024)

Beckman Coulter has become aware of an increase in customer complaints for intermittent IRISpec CB negative glucose control failure, resulting in false positive control results when used in conjunction with iChemVELOCITY Urine Chemistry Strips (PNs 800-7204 and 800-7212) on the iChemVELOCITY Analyzer. This issue may delay the reporting of patient results, with a worst-case scenario of a delay in diagnosis or treatment of metabolic disorders, kidney function abnormalities, urinary tract infections, and liver function.

FDAJul 16, 2024Nationwide• Beckman Coulter, Inc.

CADD-Solis Li-ion Rechargeable Battery Packs, REF 21-2160... (Smiths Medical ASD Inc.) – damage to the battery pack may have c... (2024)

Damage to the battery pack may have caused a short to a capacitor within the battery pack. While the battery encasement is designed to be flame retardant, a short to the capacitor could lead to melting of the battery pack case. If this issue occurs, the battery pack charging circuit may become inoperable.

FDAJul 16, 2024Nationwide• Smiths Medical ASD Inc.

Trilogy Evo EV300 -- Model Number/ Model Description: BL2... (Philips Respironics, Inc.) – firm has released a mandatory softwar... (2024)

Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for affected ventilators. These updates resolve safety issues identified in earlier recalls.

FDAJul 16, 2024Nationwide• Philips Respironics, Inc.

Trilogy Evo; Model No./Model Description -- AU2110X15B ... (Philips Respironics, Inc.) – firm has released a mandatory softwar... (2024)

Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for affected ventilators. These updates resolve safety issues identified in earlier recalls.

FDAJul 16, 2024Nationwide• Philips Respironics, Inc.

Trilogy Evo Universal Ventilator, Model No. DS2000X11B (Philips Respironics, Inc.) – firm has released a mandatory softwar... (2024)

Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for affected ventilators. These updates resolve safety issues identified in earlier recalls.

FDAJul 16, 2024Nationwide• Philips Respironics, Inc.

Total Plus Valve (Alcon) – Sharpness Complaint (2024)

Laceration Risk

Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

FDAJul 15, 2024Nationwide• Alcon Research LLC Aspex Facility

Product Name: 25+ CMB PAK 10K CPM,V,STD 0.9 Model/Catalog... (Alcon Research LLC Aspex Facility) – laceration hazard (2024)

Laceration Risk

Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

FDAJul 15, 2024Nationwide• Alcon Research LLC Aspex Facility

Total Plus Valve (Alcon) – Sharpness Complaint (2024)

Laceration Risk

Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

FDAJul 15, 2024Nationwide• Alcon Research LLC Aspex Facility

ClearCut Sideport Knife (Alcon) – Sharpness Complaint (2024)

Laceration Risk

Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

FDAJul 15, 2024Nationwide• Alcon Research LLC Aspex Facility

25+ Total Plus Pak (Alcon) – Sharpness Complaint (2024)

Laceration Risk

Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

FDAJul 15, 2024Nationwide• Alcon Research LLC Aspex Facility

Product Name: ClearCut S Safety Sideport Knife 1.0mm Dual... (Alcon Research LLC Aspex Facility) – laceration hazard (2024)

Laceration Risk

Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

FDAJul 15, 2024Nationwide• Alcon Research LLC Aspex Facility

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