Recall Z-0562-2018 ยท JAK System, X-Ray, Tomography, Computed
Philips Medical Systems (Cleveland) Inc
Ingenuity TF PET/CT (model 882442) running software version 4.0.2 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 radiopharmaceutical
| Date | Dec 11, 2017 |
| Status | Terminated |
| Reason | A software issue causes PET reconstructions to fail intermittently. It was determined that reconstructions fail due to a negative table position (-1 value is inserted) in the raw data list file, rather than the actual table position. This error has been found to occur in two scenarios: 1) When the system operator cancels an acquisition a. The error will occur every time a scan is cancelled by the operator. 2) Couch position requests within the software sequence were delayed a. The error occurs intermittently, but has been found to occur more frequently when the gantry s network is heavily load |
| Root cause | Software design |
| Action | Philips Healthcare sent an Urgent-Field Safety Notice dated December 11, 2017. U.S. Customers will be receive the letter via USPS Certified mail. Non-U.S.. customers will receive the letter through Philips Global Markets following local regulations. Philips is informing customers of the software issues on the systems, as well as available workarounds to prevent these issues from occurring or to minimize their impact. For North America and Canada, contact the Customer Care Solutions Center (1-800-722-9377, follow the prompts) |
| Quantity | 24 |
| Distribution | Worldwide Distribution - US Distribution to the states of : CA, OH, IL, PA and NY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K172406 | Ingenuity TF Philips Medical Systems (Cleveland), Inc., Oct 6, 2017 |