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Philips North America Llc

Philips North America Llc: 9 recalls listed since January 2026 across FDA.

By year

  • 20269

By agency

  • FDA9

By category

  • Medical Device9

All recalls (9)

Philips Spectral CT 7500

The Spectral CT 7500 software may crash during bolus tracking.

Moderate risk, FDA, , Device defect

Philips Achieva, Ingenia, Intera and MR MRI Systems

A software issue can terminate an examination during image reconstruction if scan parameters are manually adjusted.

Moderate risk, FDA, , Software defect

Philips Brilliance, IQon Spectral and Ingenuity CT Scanners

Philips CT systems have an unintended radiation issue that could affect equipment performance.

Moderate risk, FDA, , Device defect

Philips Cardiac Workstation 5000 and 7000

The Cardiac Workstation 5000 may provide inaccurate heart rate data.

Moderate risk, FDA, , Device defect

Philips Telemetry Monitor 5500 1.4 GHz

The Philips Telemetry Monitor 5500 1.4 GHz may reset to a default state, causing loss of configuration and failure to reconnect.

Moderate risk, FDA, , Labeling error

Philips Avalon Fetal Monitor

The Philips Avalon Fetal Monitor has incorrect speaker connector assembly that can cause loss of speaker output.

Moderate risk, FDA, , Device defect

DigitalDiagnost C90 Flex/Value/Chest/ER

The DigitalDiagnost C90 Flex/Value/Chest/ER was delivered without a required seismic kit for its Wall Stand VS2.

Moderate risk, FDA, , Device defect

Philips Brilliance iCT and Spectral CT Scanners

Spectral CT 7500 on Rails may have fasteners not torqued to specification, potentially causing rotor parts to become unsecured and expelled.

Moderate risk, FDA, , Device defect

Philips Smart-Hopping 2.0 AP 1.4 GHz Patient Monitor

It was found that the MX40 device could not reconnect to the PIC iX when moving between Radiohead and Trident 1.4 GHz access points if the signal strength changed quickly.

Moderate risk, FDA, , Device defect
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