Z-1392-2018Class II

Ingenuity TF PET/CT, Model No. 882442

Name: Z-1392-2018 Ingenuity TF PET/CT, Model No. 882442
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2018-02-15
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2018-02-15 / Terminated

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of Ingenuity TF PET/CT, Model No. 882442 Product Usage: The device is an integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography... on 2018-02-15. FDA classified it as Class II and gives the reason as "Following a period of inactivity, the mass storage device may cause the acquisition console to become unresponsive. This may prevent an acquisition from proceeding". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1392-2018
Classification: Class II
Status: Terminated
Initiated: 2018-02-15
Posted: 2018-04-17
Terminated: 2019-11-21
Recalling firm: Philips North America LLC
Product: 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 technologies increases with the capability to fuse the CT and PET images using Philips fusion viewer Image Fusion software to create a composite image for diagnostic study and therapeutic planning. The system also provides tools for the quantification of results of the CT and PET images and provides the means for a simplified review of the CT, PET, and fused images. The integration of the anatomical data from CT with the metabolic data from PET gives clinicians the visual information necessary to define the severity, as well as the extent, of the disease.
Product code: KPS System, Tomography, Computed, Emission
Reason for recall: Following a period of inactivity, the mass storage device may cause the acquisition console to become unresponsive. This may prevent an acquisition from proceeding.
FDA 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 transfer is needed. Following data transfer, the Addonics USB Mass Storage Device should be turned off. Customers were instructed to inform those who need to be aware within their organization or any organization wehre potentially affected devices have been transferred; transfer the notice to other affected organizations; and maintain the recall notice with their system Instructions For Use until the correction is made to the system. Customers were advised that Philips will be providing an updated Mass Storage Device that does not experience the same issue that will be provided at no additional cost to the customer. The Field Correction will be released in Q1 2018. Customers who need further information or support regarding the recall were directed to contact their local Philips representative. Customer Care Solutions Center: 1-800-722-9377.
Quantity in commerce: 12
Distribution: Worldwide Distribution - US Nationwide in the states of: OH and OR, and Foreign distribution to Australia, China, Cuba, France, and South Africa.
Product codes and lots: Serial No: 2090 2072 2077 2079 2086 2091 2093 2085 2076 2071 2078 2081

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1392-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1392-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-25	2018-04-17

Product code KPS

K052640Class IIGemini RaptorPhilips Medical Systems (Cleveland), Inc. / cleared 2005-10-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)