Philips Medical Systems (Cleveland) Inc IQon Spectral CT Model # 728332, computed tomography x-ray system Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
IQon Spectral CT Model # 728332, computed tomography x-ray system
Brand
Philips Medical Systems (Cleveland) Inc
Lot Codes / Batch Numbers
System Serial Number 860004 through 860043, 860046 through 860127, 890002
Products Sold
System Serial Number 860004 through 860043, 860046 through 860127, 890002
Philips Medical Systems (Cleveland) Inc is recalling IQon Spectral CT Model # 728332, computed tomography x-ray system due to In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance h. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been applied when phase tolerance had not been applied
Recommended Action
Per FDA guidance
Philips Healthcare issued a Field Safety Notification (FSN)72800720/88200522 1. Identify affected product 2. There are 3 scenarios users may experience which result in identical images that are incorrectly labeled as phase tolerance images. A. When performing a Step and Shoot acquisition with phase tolerance selected, images may be reconstructed identically (a single phase), but are labeled as different phases. This occurs when Start Final Recon is selected prior to display of the ECG wave at the top of the acquisition window. B. When performing a Step and Shoot acquisition with phase tolerance selected, images may be reconstructed identically (a single phase), but are labeled as different phases. This occurs if ECG leads become disconnected mid-acquisition or when the acquisition is halted prematurely due to an application crash. C. By system design, in certain instances when a patient exhibits an arrhythmia or varying heart rate during a Step and Shoot acquisition, images from the acquisition following the heart rate variation, may be labeled in the incorrect phase 4. Determine whether you have a potentially affected system, then determine your AFFECTED PRODUCTS software version. To identify the software version of your product: Click the Help button, Select About and the software version is then displayed, Software versions 4.x, 3.x, and 2.x are potentially affected. 5. Take the Action listed in the field safety notice. Please retain a copy with the equipment Instruction for use. If you need any further information or support concerning this issue, please contact your local Philips representative: North America and Canada, contact the Customer Care Solutions Center (1-800-722-9377 and follow the prompts).
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026