The Recall Desk
HighFDA (Devices)·Z-0376-2017·Announced 2016-11-30

Philips CT Scanner Recall Due to Potential Tabletop Movement Failure

Philips is recalling 1,363 CT scanners because the patient support tabletop may fail to move horizontally during scans due to a mechanical linkage failure.

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: The recall involves a mechanical defect in a medical device that could prevent necessary patient positioning, representing a risk of harm where injury has not yet been reported, consistent with the 'High' severity criteria.

Plain-English summary

Philips Electronics North America Corporation is recalling 1,363 units of the Philips Healthcare System X-ray Tomography Computed Tomography (CT) scanners. The affected models include the Ingenuity CT, Ingenuity Core, and Ingenuity Core 128. These devices were distributed nationwide to 35 states, including Arizona, New York, Georgia, and California.

The recall was initiated because it was discovered that the patient support tabletop may fail to move in the horizontal direction when commanded to do so during CT scans. This issue is attributed to a potential mechanical linkage failure. The source text does not report any specific injuries or illnesses associated with this defect.

Healthcare facilities and consumers who possess these specific CT scanner models should contact Philips Electronics North America Corporation for further instructions on how to address the mechanical issue. The recall number for this action is Z-0376-2017.

The recalled product

Product
Philips Healthcare System X-ray Tomography Computed :
Affected units
1,363

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 (3)

  • Ingenuity CT
  • Ingenuity Core
  • Ingenuity Core 128.

Distribution

Distributed nationwide across the United States.

The notice also names 36 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Philips Electronics North America Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Philips Electronics North America Corporation

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