Recall Z-0823-2019 ยท KPS System, Tomography, Computed, Emission
Philips Medical Systems (Cleveland) Inc
Ingenuity TF PET/CT (non-RoHS), Model Number 882456 This device is a diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patien
| Date | Dec 19, 2018 |
| Status | Terminated |
| Reason | A software update is being issued to correct multiple issues identified in the previous software version. |
| Root cause | Software design |
| Action | The firm, Philips, sent an "URGENT - Medical Device Correction" letters dated 12/19/18 to its customers. The letter describes the products, problem and actions to be taken. The customers were instructed to: review the information including (Ingenuity TF PET/CT running software version 4.0.2 (4.0.0.26645) Software Issues) Issues with all members of your staff who need to be aware of the contents of this communication; retain a copy with the equipment Instruction for Use and If you need any further information or support concerning these issues, please contact your local Philips representati |
| Quantity | 24 |
| Distribution | Worldwide distribution: US (nationwide) to states of: CA, IL, NY, OH, and PA; and to countries of: Australia, Austria, Columbia, Egypt, France, Germany, India, Italy, Lithuania, Netherlands, and Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K172406 | Ingenuity TF Philips Medical Systems (Cleveland), Inc., Oct 6, 2017 |