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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.

Moderate

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

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.

High

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

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

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

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

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

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

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

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

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

Philips Azurion Interventional Fluoroscopic X-ray System ... (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands) – potential loss of imaging (x-ray) fun... (2024)

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

25GA Valved Entry System (Alcon) – Sharpness Complaint (2024)

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

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

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

20 Gauge V-Lance Knife (Alcon) – Sharpness Complaint (2024)

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

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

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

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