The Recall Desk
HighFDA (Devices)·Z-1654-2015·Announced 2015-06-03

Philips Brilliance CT 10 Air Recalled for Unexpected Couch Descent

Philips Medical Systems is recalling 153 Brilliance CT 10 Air systems in China 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 a mechanical failure could cause injury, but the source text does not explicitly report that injuries or illnesses have occurred, fitting the criteria for a High severity score.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 153 units of the Brilliance CT 10 Air computed tomography (CT) X-ray system. These systems are intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. The affected units were distributed in China.

The recall was initiated after the firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being commanded to do so. This malfunction presents a risk of injury to patients or operators.

The affected units are identified by System Code # 728256 and specific serial numbers: 2448, 3145, 3212, 3213, 3276, 3278, 280, 3307, 3309, 3317, 3336, 30003, 30008, 30017, 30021, 30022, 30036, and 30047. Users should contact Philips Medical Systems for further instructions on how to address this issue.

The recalled product

Product
Brilliance CT 10 Air. 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 (20)

  • System Code #
  • 728256
  • Serial #
  • 2448
  • 3145
  • 3212
  • 3213
  • 3276
  • 3278
  • 280
  • 3307
  • 3309
  • 3317
  • 3336
  • 30003
  • 30008
  • 30017
  • 30021
  • 30022
  • 30036 & 30047.

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 →