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Showing 181–200 of 265 results

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Lumify Diagnostic Ultrasound System (Philips) – iOS Compatibility Issue (2025)

Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining.

FDAOct 31, 2025Nationwide• Philips Ultrasound, LLC

IntelliVue MP90 (Philips) – Alarm Failure Risk (2025)

Potential issue where the IntelliVue monitors did not alarm.

FDAOct 31, 2025Nationwide• Philips North America Llc

IntelliVue Patient Monitor MX700 (Philips) – Alarm Failure Risk (2025)

Potential issue where the IntelliVue monitors did not alarm.

Moderate

FDAOct 31, 2025Nationwide• Philips North America Llc

IntelliVue Multi-Measurement Module X3 (Philips) – monitoring alarm issue (2025)

Potential issue where the IntelliVue monitors did not alarm.

FDAOct 31, 2025Nationwide• Philips North America Llc

IntelliVue Patient Monitor MX400 (Philips) – monitoring alarm issue (2025)

Potential issue where the IntelliVue monitors did not alarm.

FDAOct 31, 2025Nationwide• Philips North America Llc

IntelliVue Patient Monitor MX100 (Philips) – monitoring alarm issue (2025)

Potential issue where the IntelliVue monitors did not alarm.

FDAOct 31, 2025Nationwide• Philips North America Llc

IntelliVue Multi Measurement Server X2 (Philips) – monitoring alarm issue (2025)

Potential issue where the IntelliVue monitors did not alarm.

FDAOct 31, 2025Nationwide• Philips North America Llc

IntelliVue MP80 (Philips) – monitoring alarm issue (2025)

Potential issue where the IntelliVue monitors did not alarm.

FDAOct 31, 2025Nationwide• Philips North America Llc

NICO Myriad Illumination Pack (Stryker) – Latex Contamination Risk (2025)

Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction.

FDAOct 31, 2025Nationwide• Stryker Corporation

IntelliVue MP2 (Philips) – Alarm Failure Risk (2025)

Potential issue where the IntelliVue monitors did not alarm.

FDAOct 31, 2025Nationwide• Philips North America Llc

IntelliVue Patient Monitor MX800 (Philips) – Alarm Failure Risk (2025)

Potential issue where the IntelliVue monitors did not alarm.

FDAOct 31, 2025Nationwide• Philips North America Llc

Stryker MV3 Bariatric Bed (Stryker) – Proximity Concern (2025)

Stryker has issued a voluntary recall of certain MV3 beds and Arise 1000EX mattresses because some of these products have been sold in close proximity, suggesting a potential intent for them to be used together. These products have not been tested for compatibility and thus are not designed to be used together. The combination of both is not recommended by Stryker.

FDAOct 31, 2025Nationwide• Stryker Medical Division of Stryker Corporation

IntelliVue MP5 (Philips) – Alarm Failure Risk (2025)

Potential issue where the IntelliVue monitors did not alarm.

FDAOct 31, 2025Nationwide• Philips North America Llc

IntelliVue MP50 (Philips) – Alarm Failure Risk (2025)

Potential issue where the IntelliVue monitors did not alarm.

FDAOct 31, 2025Nationwide• Philips North America Llc

IntelliVue Patient Monitor MX600 (Philips) – Alarm Failure Risk (2025)

Potential issue where the IntelliVue monitors did not alarm.

FDAOct 31, 2025Nationwide• Philips North America Llc

NICO BrainPath (Stryker) – latex packaging issue (2025)

Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction.

FDAOct 31, 2025Nationwide• Stryker Corporation

Olympus OER-Pro (Aizu Olympus) – Maintenance Warning (2025)

Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.

FDAOct 31, 2025Nationwide• Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan

NICO Myriad Handpiece (Stryker) – Latex Contamination Risk (2025)

Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction.

FDAOct 31, 2025Nationwide• Stryker Corporation

IntelliVue Patient Monitor MX500 (Philips) – Alarm Failure Risk (2025)

Potential issue where the IntelliVue monitors did not alarm.

FDAOct 31, 2025Nationwide• Philips North America Llc

Olympus OER-Elite (Aizu Olympus) – Maintenance Warning (2025)

Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.

FDAOct 31, 2025Nationwide• Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan

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