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Revaclear 400 Dialyzer (Baxter) – Gasket Twisting Issue (2022)

Potential for Internal Blood Leaks due to a twisted gasket in the dialyzer

FDANov 23, 2022Nationwide• Baxter Healthcare Corporation

Luminos dRF Max (Siemens) – Fluoroscopic Display Error (2022)

Under certain unlikely circumstances during a fluoroscopic examination, the imaging system Fluorospot Compact might sporadically display an incorrect air kerma/air kerma rate related to the patient reference point, according to IEC 60601-2-43. There is no impact on workflow or diagnosis. The error can occur only in fluoroscopy systems with a second (overhead) X-ray tube.

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FDANov 23, 2022Nationwide• Siemens Medical Solutions USA, Inc

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Revaclear 400 Dialyzer (Baxter) – Gasket Twisting Issue (2022)

Luminos dRF Max (Siemens) – Fluoroscopic Display Error (2022)

Emprint Ablation Catheter (Covidien) – Incorrect Expiration (2022)

Luminos Agile Max (Siemens) – Fluoroscopic Display Error (2022)

Ingenia Elition S MR System (Philips) – Gradient Coil Fire Risk (2022)

SmartPath to Elition X (Philips) – Gradient Coil Fire Risk (2022)

Specific Protein Control (Randox) – Rheumatoid Factor Decrease (2022)

MR 7700 System Upgrade (Philips) – Gradient Coil Fire Risk (2022)

MR 7700 System (Philips) – Gradient Coil Fire Risk (2022)

Alinity m Resp-4-Plex Kit (Abbott) – False Result Risk (2022)

Ingenia Elition X MR System (Philips) – Gradient Coil Fire Risk (2022)

Proveo 8 Microscope (Leica) – Power Supply Overheat (2022)

Guardian Glucose Monitoring App (Medtronic) – Logout Issue (2022)

BBL Chocolate II Agar (Becton Dickinson) – Nutrient Concentration Issue (2022)

Fetal Spiral Electrode (Philips) – Tip Breaking Risk (2022)

Provido Microscope (Leica) – Power Supply Overheat (2022)

M530 OHX Microscope (Leica) – Power Supply Overheat (2022)

4Kscore Test (BioReference) – Software Anomalies (2022)

Electrosurgical Suction Coagulator (ConMed) – Suction Port Occlusion (2022)

Presource IV Start Kit (Cardinal Health) – Connector Defect (2022)