The Recall Desk
HighFDA (Devices)·Z-1573-2016·Announced 2016-05-04

Philips NeuViz 16 CT Scanner Recall for Patient Data Error

Philips and Neusoft are recalling 37 NeuViz 16 CT scanners due to a software defect that may allow previous patient images to be pasted into the current patient's record.

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 software error could lead to incorrect patient imaging, but the source text does not report any specific injuries or illnesses.

Plain-English summary

Philips and Neusoft Medical Systems Co., Ltd. are recalling 37 units of the NeuViz 16 Multi-Slice CT Scanner System. The recall affects specific serial numbers listed in the agency notice and is limited to systems running software versions 1.1.4.21425 and 1.1.4.21426.

The recall is due to a software defect in the MX 16-slice console. During filming operations, the clipboard used for copying and pasting images is not cleared between patients. If an operator fails to copy the current patient's images before pasting, a previous patient's image may remain in the clipboard and be pasted into the current patient's record.

The affected units were distributed in North Carolina, Ohio, Nebraska, South Carolina, Texas, Louisiana, Puerto Rico, Missouri, Florida, and Connecticut. Healthcare facilities should contact the recalling firm for instructions on how to resolve the software issue.

The recalled product

Product
NeuViz 16 Multi-Slice CT Scanner System PN: 989605858501 a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array with multi-slice capability up to 16 slices simultaneously.
Affected units
37

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)

  • Serial Numbers: N16E090002
  • N16E090003
  • N16E090007
  • N16E090008
  • N16E090010
  • N16E100023
  • N16E110023
  • N16E110026
  • N16E120016
  • N16E120023
  • N16E120052
  • N16E120053
  • N16E130012
  • N16E130038
  • N16E130045
  • N16E140008
  • N16E140007
  • N16E140012
  • N16E140017
  • N16E140020

Distribution

Distributed in 10 states:

Same manufacturer · Philips and Neusoft Medical Systems Co., Ltd.

See all →