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.
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 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
- 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
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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