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

Potential issue where the IntelliVue monitors did not alarm.

High

FDAOct 31, 2025Nationwide• Philips North America Llc

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

Potential issue where the IntelliVue monitors did not alarm.

High

FDAOct 31, 2025Nationwide• Philips North America Llc

FlexLab FLX-217-10 (Inpeco) – Labeling Mismatch Risk (2025)

The Aliquoter Module (mALX) may generate secondary sample tubes without labels or with mismatched labels which may result in delayed results or erroneous results. This error occurs if the operators open the printer head of mALX to perform error recoveries or maintenance procedures and do not empty the printer tubes buffer to remove all the secondary sample tubes.

Moderate

FDAOct 30, 2025MI• Inpeco S.A. Via San Gottardo 10 Lugano Switzerland

Single Use Ligating Device (Olympus) – Loop Detachment Issue (2025)

Potential that the ligation loop was unable to release or detach as expected during use, causing the loop to become unintentionally fixed around patient anatomy.

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

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

FlexLab FLX-217-10 (Inpeco) – Labeling Mismatch Risk (2025)

Single Use Ligating Device (Olympus) – Loop Detachment Issue (2025)

FlexLab FLX-217-40 (Inpeco) – Labeling Mismatch Risk (2025)

Xpert BCR-ABL Ultra (Cepheid) – Test Result Inaccuracy (2025)

Vista Set (B Braun) – Medication Backflow Risk (2025)

RATE FLOW Set (B Braun) – Medication Backflow Risk (2025)

Burette Set (B Braun) – Medication Backflow Risk (2025)

Infusomat Set (B Braun) – Medication Backflow Risk (2025)

Caresite Set (B Braun) – Medication Backflow Risk (2025)

Incisive CT (Philips) – Scanner Component Detachment (2025)

Anesthesia IV Set (B Braun) – Medication Backflow Risk (2025)

DTT Respiratory Specimen (Copan) – Reagent Functionality Issue (2025)

Outlook Set (B Braun) – Medication Backflow Risk (2025)

Extension Set (B Braun) – Medication Backflow Risk (2025)

CARESAFE Set (B Braun) – Medication Backflow Risk (2025)

SafeDAY Set (B Braun) – Medication Backflow Risk (2025)

SAFELINE Set (B Braun) – Medication Backflow Risk (2025)

ULTRASITE Set (B Braun) – Medication Backflow Risk (2025)