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Radiology Solutions (Change Healthcare) – record update issue (2023)

Change Healthcare has identified a software issue where Change Healthcare Radiology Solutions 14.0, 14.1, and 14.2 may not update records in external applications.

Low

FDAOct 12, 2023Nationwide• CHANGE HEALTHCARE CANADA COMPANY

EVIS EXERA II Bronchovideoscope (Olympus) – combustion risk (2023)

There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the electrosurgical accessory is too close to the distal end of the endoscope.

High

FDAOct 12, 2023Nationwide• Olympus Corporation of the Americas

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Radiology Solutions (Change Healthcare) – record update issue (2023)

EVIS EXERA II Bronchovideoscope (Olympus) – combustion risk (2023)

EVIS EXERA III Bronchovideoscope (Olympus) – combustion risk (2023)

Mo.Ma Ultra Device (Medtronic) – labeling issue (2023)

BD Gravity Sets (Becton Dickinson) – DEHP Mislabeling (2023)

Horizon Manual Resuscitators (SunMed Holdings) – CO2 Rebreathing Risk (2023)

VariSoft Infusion Set (Unomedical A/S) – Connector Damage (2023)

RANDOX Total Bilirubin (Randox Laboratories) – Elevated Patient Results (2023)

Medline Resuscitator (SunMed) – CO2 rebreathing risk (2023)

Nautilus ECMO Oxygenator (Unknown) – heat exchange problem (2023)

V-Care Manual Resuscitators (SunMed Holdings) – CO2 Rebreathing Risk (2023)

BreathTech Manual Resuscitators (SunMed Holdings) – CO2 Rebreathing Risk (2023)

Curaplex Manual Resuscitators (SunMed Holdings) – CO2 Rebreathing Risk (2023)

BD Extension Sets (Becton Dickinson) – DEHP Mislabeling (2023)

AirFlow Manual Resuscitators (SunMed Holdings) – CO2 Rebreathing Risk (2023)

SafeSpot Manual Resuscitators (SunMed Holdings) – CO2 Rebreathing Risk (2023)

Nautilus Smart ECMO Module (Unknown) – heat exchange problem (2023)

Ventlab STAT-Check Resuscitator (SunMed) – CO2 rebreathing risk (2023)

BD Alaris Pump Infusion Sets (Becton Dickinson) – DEHP Mislabeling (2023)

RescuMed Manual Resuscitators (SunMed Holdings) – CO2 Rebreathing Risk (2023)