The Recall Desk
HighFDA (Devices)·Z-1506-2016·Announced 2016-04-27

Philips AutoSPECT Pro Software Recalled for Incorrect Cardiac Image Reconstruction

Philips Medical Systems is recalling 33 units of AutoSPECT Pro software because it may incorrectly reconstruct cardiac SPECT data acquired at non-standard detector angles.

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 that may produce erroneous diagnostic results, which poses a risk of harm to patients, but no specific injuries or illnesses have been reported in the source text.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 33 units of the IntelliSpace Portal DX/HX/EX AutoSPECT Pro Software Application. The software is used to process, analyze, and display medical images and data. The recall is due to a design limitation where the application was only intended to reconstruct cardiac SPECT data obtained with detectors positioned at 90 or 180 degrees relative to one another.

Certain gamma cameras allow for other relative detector angles. When data is acquired at these other angles, the AutoSPECT Pro application will not correctly reconstruct the data, and the results will likely be erroneous. The affected units were distributed worldwide, including in the United States and various international countries.

No specific instructions for consumers are provided in the source text, but the recall indicates that the software may produce erroneous results for specific data configurations.

The recalled product

Product
IntelliSpace Portal DX/HX/EX 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
33

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 881001
  • S/N: 85254
  • 82202
  • 85330
  • 82117
  • 7000022
  • 105009
  • 970001
  • 850001
  • 870030
  • 82141
  • 95068
  • 87182
  • 87197
  • 95078
  • 82140
  • 11017
  • 98139
  • 95035
  • 87200

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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