Recall Z-2193-2019 ยท JAK System, X-Ray, Tomography, Computed
Philips Medical Systems (Cleveland) Inc
Ingenuity TF PET/CT Model # 882456, computed tomography x-ray system
| Date | Aug 6, 2019 (initiated Jun 24, 2019) |
| Status | Terminated |
| Reason | 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 |
| Root cause | Other |
| Action | 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 tol |
| Quantity | 12 |
| Distribution | Worldwide distribution. US nationwide including Puerto Rico, Canada, Mexico, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Cambodia, Cayman Islands, Chile, China, Colombia, Cote D'Ivoir |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K172406 | Ingenuity TF Philips Medical Systems (Cleveland), Inc., Oct 6, 2017 |