Philips AutoSPECT Pro Software Recalled for Incorrect Cardiac Image Reconstruction
Philips Medical Systems is recalling the AutoSPECT Pro software application because it may incorrectly reconstruct cardiac SPECT data acquired with 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 is classified as FDA Class II, and the hazard involves the potential for erroneous medical image reconstruction, which poses a risk of harm to patients, although no specific injuries or illnesses are reported in the source text.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling the Extended Brilliance Workspace NM Special Nuclear medicine image display and processing application suite, specifically the AutoSPECT Pro Software Application. The recall involves 37 units of the software.
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 AutoSPECT Pro, and the results will likely be erroneous.
The affected software was distributed worldwide, including in the United States and various international countries. Users should contact Philips Medical Systems for further instructions regarding the recall.
The recalled product
- Product
- Extended Brilliance Workspace NM Special 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
- 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)
- M/N 882488
- S/N: 66565
- 66586
- 66589
- 66670
- 66681
- 66672
- 66644
- 66888
- 66374
- 66371
- 66305
- 66824
- 66261
- 66356
- 66059
- 66056
- 67027
- 66248
- 66590
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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