Moderate riskFDA DeviceClass II

Philips Incisive CT scanner recalled for incomplete scans due to sensor connection issue

Philips Healthcare has recalled certain Incisive CT scanners due to an unstable internal connection in the floating sensor. This instability may cause the scanner to produce incomplete or compromised scans. The issue affects 35 devices distributed across the U.S. and its territories, and no injuries have been reported.

From the FDA notice · Read the official notice ↗ · All Philips recalls

What to do

  1. Contact Philips Healthcare immediately if your facility operates an affected Incisive CT scanner
  2. Do not perform patient scans until you receive inspection or replacement guidance from Philips
  3. Check your device serial number against Philips' recall list to confirm if your unit is affected

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Philips Incisive CT
Sold in
Nationwide
Made for
All ages (0 months and older)

Details

Units affected
35
Illnesses reported
None reported
Manufactured in
Suzhou Industrial Park, No. 258 Zhongyuan Road; Pingjiang, Suzhou, China
Classification
Class II
Recall number
Z-1003-2026

In the FDA's words

Description
Philips Incisive CT Potential for incomplete scan due to unstable connection inside of floating sensor. Distribution: U.S. and U.S. territories Affected quantity: 35
Hazard
Potential for incomplete scan due to unstable connection inside of floating sensor.

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