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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- 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
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.
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