Philips Medical Systems (Cleveland) Inc Ingenuity CT, Model # 728326, computed tomography x-ray system Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Ingenuity CT, Model # 728326, computed tomography x-ray system
Brand
Philips Medical Systems (Cleveland) Inc
Lot Codes / Batch Numbers
System Serial Number 10474, 30003, 30005, 30006 through 30009, 30011 through 30015, 30017 through 30050, 30053-30054, 30056, 52035, 52049, 52051, 100367 122276, 300003 Through 300005, 300010 through 300012, 300014, 300016 through 300066, 300068 through 300135, 300136 through 300145, 300147 through 300151, 300153- 300154, 300156 through 300166, 300200 through 300263, 320127, 336053, 339001, 339007, 339008, 339009, 30004-1, 336124
Products Sold
System Serial Number 10474, 30003, 30005, 30006 through 30009, 30011 through 30015, 30017 through 30050, 30053-30054, 30056, 52035, 52049,52051,100367 122276, 300003 Through 300005, 300010 through 300012, 300014, 300016 through 300066, 300068 through 300135, 300136 through 300145, 300147 through 300151, 300153- 300154, 300156 through 300166, 300200 through 300263, 320127, 336053, 339001, 339007, 339008, 339009, 30004-1, 336124
Philips Medical Systems (Cleveland) Inc is recalling Ingenuity CT, Model # 728326, 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