The Recall Desk
HighFDA (Devices)·Z-0375-2017·Announced 2016-11-30

Philips CT Scanner Recall Due to 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 during a scan. This fits the rubric criterion for 'risk-of-harm products where injury has not yet been reported,' as no specific injuries or illnesses are mentioned in the source text.

Plain-English summary

Philips Electronics North America Corporation is recalling 1,363 units of Philips Healthcare System X-ray Tomography Computed scanners. The affected models include the Brilliance iCT SP, Brilliance iCT, Brilliance 64, Brilliance 40, Brilliance 16, Brilliance 16P, Brilliance 10, Brilliance 6, and Brilliance Big Bore.

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 affected units were distributed nationwide in the United States to the states of AZ, NY, GA, UT, TN, TX, AR, NV, IL, FL, MS, LA, MD, MO, MA, OK, KY, WY, SC, ND, NE, DE, MI, WA, CT, RI, KS, OR, IN, PA, CA, NJ, NC, MN, AL, and IA. Healthcare facilities should contact Philips for further instructions on how to address this defect.

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 (9)

  • Brilliance iCT SP
  • Brilliance iCT
  • Brilliance 64
  • Brilliance 40
  • Brilliance 16
  • Brilliance 16P
  • Brilliance 10
  • Brilliance 6
  • Brilliance Big Bore.

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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