The Recall Desk
HighFDA (Devices)·Z-1504-2016·Announced 2016-04-27

Philips AutoSPECT Pro Software Recalled for Incorrect Cardiac Image Reconstruction

Philips Medical Systems is recalling the AutoSPECT Pro software application because it may produce erroneous results when processing cardiac SPECT data acquired at detector angles other than 90 or 180 degrees.

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 medical device software defect that produces erroneous diagnostic results, which poses a risk of harm to patients through potential misdiagnosis, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 126 units of the Extended Brilliance Workspace NM Nuclear medicine image display and processing application suite, specifically the AutoSPECT Pro Software Application. The software is used to process, analyze, and display medical images and data.

The recall was initiated because the AutoSPECT Pro application was designed only to reconstruct cardiac SPECT data obtained with detectors positioned at 90 or 180 degrees relative to one another. However, certain gamma cameras allow for other relative detector angles. Data acquired at these other angles will not be correctly reconstructed by the software, and the results will likely be erroneous.

The affected units were distributed worldwide, including in the United States and various international countries. The source text does not specify instructions for consumers or healthcare providers on how to proceed with the recall.

The recalled product

Product
Extended Brilliance Workspace NM Nuclear medicine image display and processing application suite. AutoSPECT Pro Software Application. Philips Medical Systems, Cleveland, OH. Provides software applications used to process, analyze, and display medical images/data.
Manufacturer
Philips Medical Systems (Cleveland) Inc
Category
Medical Device — Software
Hazard
Affected units
126

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)

  • M/N 882489
  • S/N: 66794
  • 66798
  • 66836
  • 66009
  • 66011
  • 67154
  • 66828
  • 67058
  • 67050
  • 67031
  • 67284
  • 66332
  • 66335
  • 66397
  • 67026
  • 67040
  • 66084
  • 66089
  • 66092

Distribution

Distributed in 16 states:

Part of a larger recall action

This product is one of 3 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 3 products in this recall →

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