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Prucka 3 Amplifiers (GE Medical) – Power Supply Failure (2023)

A diode on the power supply of the Prucka 3 Amplifier used with CardioLab/ComboLab systems could reach elevated temperatures and fail, then power off and become inoperable.

Moderate

FDAAug 8, 2023CA, CO, FL +14 more• GE Medical Systems Information Technologies Inc

Oculus Myopia Master (Oculus) – Coating Measurement Risk (2023)

Their is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements.

Moderate

FDAAug 8, 2023Nationwide• Oculus Optikgeraete GMBH Munchholzhauser Str. 29 Wetzlar Germany

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Prucka 3 Amplifiers (GE Medical) – Power Supply Failure (2023)

Oculus Myopia Master (Oculus) – Coating Measurement Risk (2023)

ADVIA Chemistry Iron Reagents (Siemens) – QC Result Bias (2023)

Fresenius 10ML Syringe (Fresenius) – Leakage Potential (2023)

Fresenius 3ML Syringe (Fresenius) – Leakage Potential (2023)

Oculus Pentacam AXL Wave (Oculus) – Coating Measurement Risk (2023)

Mallinckrodt One-Way Valve (Mallinckrodt) – Airflow Restriction (2023)

Fresenius 10ML Syringe with Needle (Fresenius) – Leakage Potential (2023)

B. Braun NORM-JECT Luer Solo (B. Braun) – Packaging Sterility (2023)

Heartmate 3 LVAS Kit (Thoratec) – Coring Knife Sharpness (2023)

Stryker ACM Cement Mixing System (Stryker) – Nozzle Breakage Risk (2023)

B. Braun NORM-JECT Luer Lock (B. Braun) – Packaging Sterility (2023)

VITROS XT ALKP Slides (Ortho-Clinical) – Substrate Depletion (2023)

VITROS XT TBIL-ALKP Slides (Ortho-Clinical) – Substrate Depletion (2023)

Hudson RCI Addipak (Medline) – Sterility Failure (2023)

Empowr Knee Baseplate (DJO Surgical) – sterilization issue (2023)

Delta Ceramic Femoral Head (DJO Surgical) – sterilization issue (2023)

CLP Hip Stem (DJO Surgical) – sterilization issue (2023)

Reverse Shoulder System Socket Insert (DJO Surgical) – sterilization issue (2023)

Altivate Reverse Humeral Stem (DJO) – Sterilization Omission (2023)