The Recall Desk
HighFDA (Devices)·Z-2035-2012·Announced 2012-07-25

Philips Brilliance CT Scanners Recalled for Defective Carbon Table Top Bolts

Philips Medical Systems is recalling 524 Brilliance CT scanners because defective bolts securing the carbon table top may break off.

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 structural defect in a medical device where a component (bolt head) may break off, posing a risk of harm to patients or operators. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High (3).

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 524 units of Philips Brilliance 6, 16, 40, 64, Big Bore, iCT, and iCT SP Computed Tomography X-Ray Systems. The recall is due to a defect in the sixteen bolts that secure the brackets supporting the carbon table top on these scanners.

The company was notified that the bolt heads on these specific bolts may break off. The affected devices are distributed worldwide, including nationwide in the United States and in numerous other countries. Specific model numbers and serial numbers for the affected units are listed in the official recall documentation.

Healthcare facilities and consumers should contact Philips Medical Systems for instructions on how to address the defective bolts. No injuries or illnesses have been reported in the source text.

The recalled product

Product
Philips Brilliance 6, 16, 40, 64, Big Bore, iCT and iCT SP are Computed Tomography X-Ray Systems. The devices are Computed Tomography Systems that are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at differen
Manufacturer
Philips Medical Systems (Cleveland) Inc
Category
Medical Device — Computed Tomography (CT) Scanner
Hazard
Affected units
524

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 (20)

  • Brilliance 64
  • M/N #728231
  • Serial #s
  • 10140
  • 10141
  • 10142
  • 10143
  • 10144
  • 10145
  • 10146
  • 10147
  • 10148
  • 10149
  • 10150
  • 10151
  • 10152
  • 10153
  • 10154
  • 10155
  • 10156

Distribution

Distributed nationwide across the United States.

The notice also names 36 states specifically:

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