The Recall Desk
ModerateFDA (Devices)·Z-2666-2014·Announced 2014-09-24

Philips Brilliance CT Big Bore Recalled for Emergency Stop Defect

Philips Medical Systems is recalling 257 Brilliance CT Big Bore systems because the emergency stop function may activate while the system is idle, halting all movements and scans.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text indicates the issue occurred only once and resulted in the cessation of movement/scan rather than a reported injury or hospitalization, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 257 units of the Brilliance CT Big Bore whole-body Computed Tomography X-ray system, specifically model numbers 728244 and 728243. The recall was initiated after the company received a complaint stating that the system's emergency stop function opened while the unit was sitting idle. This malfunction caused all movements and the scan to stop.

The issue has only occurred one time, specifically when the scan was out of 'Ready for Scan' or scanning mode. The affected units were distributed nationwide, including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, MA, MD, MI, MN, MO, MS, NC, ND, NH, NJ, NM, NY, OH, OK, OR, PA, TN, TX, VA, WA, and WI.

Healthcare facilities should check their equipment serial numbers against the list provided by the manufacturer to determine if their unit is affected. No specific consumer action is required for the general public, as these are professional medical devices.

The recalled product

Product
The Brilliance CT Big Bore is a whole-body Computed Tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data from the same axial plane taken at different angles. Model Numbers 728244 and 728243.
Manufacturer
Philips Medical Systems (Cleveland) Inc
Category
Medical Device — Imaging Equipment
Hazard
Affected units
257

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)

  • System Code #
  • 728243
  • 728244
  • Serial #: 7022
  • 7118
  • 7151
  • 7298
  • 7343
  • 7360
  • 7361
  • 7362
  • 7363
  • 7364
  • 7365
  • 7366
  • 7367
  • 7368
  • 7369
  • 7370
  • 7371

Distribution

Distributed nationwide across the United States.

The notice also names 35 states specifically:

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