Safety Alerts

Safety Alerts

Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.

Medical Device Safety Alert: Philips Medical Systems Nederland B.V. MR systems with software version R5.7.1

04 May 2024

Medical device manufacturer, Philips Medical Systems Nederland B.V., has issued a medical device safety alert concerning its MR systems with software version R5.7.1 [Model: Achieva 1.5T, Achieva 1.5T Conversion, Achieva 1.5T Initial system, Achieva 3.0T, Achieva XR, Ingenia 1.5T, Ingenia 1.5T CX, Ingenia 1.5T S, Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Ambition S, Ingenia Ambition X, Ingenia Elition S, Ingenia Elition X, Ingenia LS, Intera 1.5T, Intera 1.5T Achieva Nova, Intera 1.5T Achieva Nova-Dual, Intera 1.5T Explorer/Nova Dual, Intera Achieva 1.5T Pulsar, Marlin 1.5T, MR system 1.5T Marlin, SmartPath to dStream for 1.5T, SmartPath to dStream for XR and 3.0T, SmartPath to Ingenia Elition X, Upgrades Achieva/Intera to R5.7] [HKMD No.: 110311,110501, 120210, 190186, 190390, 200408, 200409].

According to the manufacturer, the manufacturer has identified multiple software issues affecting Philips MR systems with software version R5.7.1. The issues have no associated safety impact but may impact clinical workflow. Detailed descriptions of software issues are shown as follow:

  1. Gradient Error message appears and scan aborts
  2. Scans with cardiac triggering may not run even though VCG signal is correct
  3. Stopping the B1 calibration scan with "stop scan" command before it is complete will cause application to freeze and prevent scans from running
  4. Compressed SENSE SWIp scan may abort and not produce any images
  5. Software may crash on first scan after a system reboot
  6. VitalScreen on the magnet does not turn off during scanning, potentially causing artifact to appear on images
  7. No images found in PACS and error message process SCU crashed is displayed
  8. DWI scan aborts due to error
  9. Long reconstruction times may occur when scanning Compressed SENSE scans in combination with the 32 channel Head coil
  10. Tabletop movement cannot be initiated from the User interface at the operators console
  11. Compressed SENSE scans may have one or more slices 'blank' (white/grey or black image) or show artifacts
  12. Parameter conflict occurs when TE, TR, and/or Waterfat shift are set to user-defined values

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 04 May 2024

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