The Recall Desk
HighFDA (Devices)·Z-1651-2015·Announced 2015-06-03

Philips Brilliance CT 16 Power Recalled for Unexpected Couch Descent

Philips is recalling 153 Brilliance CT 16 Power systems because the patient couch may unexpectedly descend during an exam.

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 risk-of-harm product (medical device) where the hazard is an unexpected mechanical movement that could cause injury, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 153 units of the Brilliance CT 16 Power computed tomography X-ray system. The recall was initiated after the firm was informed that while raising the patient couch to perform an exam, the couch unexpectedly descended to the lowest point without being commanded to do so.

The affected systems were distributed in China. The specific system code is 728240 and the serial number is 60008. The product is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

No specific instructions for consumers or healthcare providers are provided in the source text regarding immediate actions to take, such as stopping use or contacting a representative.

The recalled product

Product
Brilliance CT 16 Power. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Affected units
153

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 (4)

  • System Code #
  • 728240
  • Serial #
  • 60008.

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 11 recalled by Philips Medical Systems (Cleveland) Inc 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 11 products in this recall →