Recall Z-1392-2018 ยท KPS System, Tomography, Computed, Emission
Philips Medical Systems (Cleveland) Inc
Ingenuity TF PET/CT, Model No. 882442 Product Usage: The device is an integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) system suitable for a wide range of diagnostic applications. The device utilizes the CT technology to obtain anatomic images of the human body and PET technology to obtain functional images of the human body. The clinical value of both t
| Date | Feb 15, 2018 |
| Status | Terminated |
| Reason | Following a period of inactivity, the mass storage device may cause the acquisition console to become unresponsive. This may prevent an acquisition from proceeding. |
| Root cause | Under Investigation by firm |
| Action | On February 15, 2018, the recalling firm notified customers of the recall via letter. The notice stated that to avoid the hazard of performing a rescan or reinjection, all users must be informed not to view studies or access data on the Addonics MSD while a patient is being scanned. If a user is attempting to view information stored on the Addonics MSD and the console appears to be unresponsive, reset power on the Addonics MSD or pull out and reconnect its USB cable. It is recommended that the Addonics USB Mass Storage Device be turned off when not being accessed, and powered on only when data |
| Quantity | 12 |
| Distribution | Worldwide Distribution - US Nationwide in the states of: OH and OR, and Foreign distribution to Australia, China, Cuba, France, and South Africa. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052640 | GEMINI RAPTOR Philips Medical Systems (Cleveland), Inc., Oct 7, 2005 |