The Recall Desk
HighFDA (Devices)·Z-0640-2024·Announced 2024-01-17

Philips Incisive CT Scanner Software Issues May Cause Misdiagnosis

Philips is recalling Incisive CT scanners due to nine software defects including image artifacts, incorrect orientation labels, display failures, and positioning errors that could lead to misdiagnosis or need for rescans. No illnesses have been reported.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Class II FDA recall of diagnostic imaging device where software defects create risk of misdiagnosis through image artifacts and incorrect orientation labels. No reported illnesses or injuries, so severity does not reach Critical or Severe level, but serious potential diagnostic harm justifies High severity.

Plain-English summary

Philips Healthcare is recalling Incisive CT scanner models 728143 and 728144 running software version 5.0.0. These are medical imaging devices used to perform computed tomography (CT) scans in healthcare facilities. A total of 828 units have been distributed worldwide, including throughout the United States.

The recall was issued due to multiple software defects. Specific issues include artifacts on perfusion images, reversed orientation labels on 2D images, missing image reconstructions, no image display after certain scan modes are enabled, ring artifacts in bone scans, design defects in couch positioning, and calcium scoring data being split into separate series. Additionally, voice prompts during cardiac scans may not function, and audio volume may be insufficient for patient communication.

These issues could result in misdiagnosis or the need to repeat CT scans, potentially delaying patient treatment and increasing radiation exposure. Healthcare facilities using these systems worldwide are affected, including locations across all U.S. states and more than 50 countries. No illnesses or injuries have been reported to the FDA.

Facilities using affected Philips Incisive CT scanners should contact Philips Healthcare for a software update. Healthcare providers should review recent scans performed with the affected equipment to determine whether images are affected and whether clinical decisions need to be reconsidered.

The recalled product

Product
Incisive CT, model 728143 & 728144 running Software Version 5.0.0.
Manufacturer
Philips Healthcare (Suzhou) Co., Ltd.
Category
Medical Device — CT Scanner
Hazard
  • image-artifact
  • image-orientation-error
  • software-defect
  • reconstruction-error
  • display-defect
  • couch-positioning-defect
  • audio-defect

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • UDI-DI: 00884838085015 (Model 728143) UDI-DI: 00884838105508 (Model 728144)

Distribution

Distributed nationwide across the United States.

Related recalls

Same category