Spectral CT on Rails, Software Version Number 5.1.0, Model… recallZ-1324-2025 · Philips Medical Systems Nederland B.V. · initiated Feb 28, 2025

Why it was recalled

Multiple problems identified with the software version leading to various scanning and image issues, and unintended device movement.

FDA root cause category: Under Investigation by firm

What the company is doing

On February 28, 2025 URGENT MEDICAL DEVICE CORRECTION letters were sent to customers. Actions that should be taken by the customer / user in order to prevent risks for patients or users. " You may continue to use your system(s) in accordance with the intended use and by following the recommendation listed below. " When you see the warning message No communication with table and C-arm. Avoid collisions, Proceed with caution., acknowledge the message by selecting OK and continue using the CT while observing with extra care, collision with the Gantry and C-arm can be avoided. " To protect the patient and the operator from a potential collision due to an automatic gantry motion during scan and plan box not updated during interventional procedure issues, follow the instructions mentioned in the IFU Section 4 Preparing for an Examination and Sub section Gantry Operation: o During all movements of the gantry (automatic and manual), keep the patient under continuous observation. o Take care to avoid pressing the patient against the gantry or between table parts, as well as to avoid disconnecting any infusion or resuscitation apparatus. o For all patient table types, take care when using attachments to avoid collision with the gantry. o Make sure that the patient is strapped securely to avoid dangling of the hands. Ensure that the patient is placed securely on the patient table and is not in danger of falling. o Auto scan means that automatic motions are expected without using the enable button. Ensure the patient table does not collide with the gantry during movement. o During studies, the gantry movements (if applicable) are automatic. Ensure enough clearance between the patient and the gantry. Before initiating the scan, perform manual movements to check the clearance. " To avoid cone beam auto correction artifacts: 1) Reduce the collimation to 32 for brain study, or reduce the collimation to 112 (or any value below 128) for body imaging, which will turn CBAC off. Refer t

Recall details

Recall number

Z-1324-2025

Status

Open, Classified

Initiated by the company

Feb 28, 2025

Posted by the FDA

Mar 12, 2025

Recalling firm

Philips Medical Systems Nederland B.V.

Quantity

1 unit

Product code

JAK

FDA submissions

K212875

Distribution

Domestic: MN

Product description

Spectral CT on Rails, Software Version Number 5.1.0, Model number: 728334;

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• Spectral CT on Rails

  Philips Medical Systems Nederland B.V. · System, X-Ray, Tomography, Computed
  6 recalls0 reports