The Recall Desk
HighFDA (Devices)·Z-0019-2014·Announced 2013-10-23

Philips MX 16-Slice CT Scanner Recalled for Pinch Point Injury Risk

Philips Medical Systems is recalling 326 MX 16-Slice CT Scanner Systems because a pinch point at the end of the table top can cause injury.

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 injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 326 units of the MX 16-Slice CT Scanner System. These devices are used as whole-body computed tomography X-Ray systems. The recall is due to a pinch point located at the end of the table top, which can cause injury.

The affected units were distributed worldwide, including in the United States and numerous international countries. The source text does not specify the number of reported injuries or illnesses associated with this defect.

Healthcare facilities and users should contact Philips Medical Systems for instructions on how to address the pinch point hazard. The recall number is Z-0019-2014.

The recalled product

Product
MX 16-Slice CT Scanner System. Used as a whole-body computed tomography X-Ray system.
Affected units
326

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)

  • Model # 728131  510(k) K083498  Serial #: EP16E090001
  • EP16E090002
  • EP16E090003
  • EP16E090006
  • EP16E090009
  • EP16E090010
  • EP16E090011
  • EP16E090012
  • EP16E090013
  • EP16E090015
  • EP16E100001
  • EP16E100004
  • EP16E100006
  • EP16E100008
  • EP16E100010
  • EP16E100012
  • EP16E100013
  • EP16E100016
  • EP16E100017
  • EP16E100018

Distribution

Distributed in 16 states: