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Safety Alerts and Communications

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. Spectral CT with software version 5.0.X

21 Nov 2024

Medical device manufacturer, Philips Medical Systems Nederland B.V., has issued a medical device safety alert concerning its Spectral CT with software version 5.0.X [HKMD No.: 220236].

Philips has become aware of a plan box not updated issue during Interventional procedure with Spectral CT that may lead to a collision with the operator or with the needle placed inside the patient, and an incorrect patient ID software issue that may lead to misdiagnosis.

1. Plan Box not Updated during Interventional Procedure:

The Plan Box may not move to the desired Needle Position orWork Position under the following circumstances:

  • Operator manually edits the Needle Position or Work Position value, and
  • Operator moves Plan Box by dragging it or by changing its center value and plan box position, and then
  • Operator uses Interventional Controls Move to Selected <Scan>/<Work> Position buttons.
This issue could result in the table moving to a location the operator does not expect. If this occurs, it presents a risk that the scan could occur at an incorrect location, or that the unintended motion of the table could cause a collision with the user or needle.

2. Incorrect Patient ID:

Philips has identified that there is a software issue that can incorrectly set the patient ID for anonymous study. If Anonymous is selected in the Patient tab, the system may not automatically set the patient ID with an increment of 1.

The issue does not occur if the operator immediately renames the Anonymous record with the patient’s name at the time of the scan. The other patient fields are not impacted. This situation may occur after receiving an error message that cannot be cleared unless the system is restarted.

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

Posted on 21 Nov 2024

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