Z-0522-2018Class II

Ingenuity TF PET/CT - a integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography...

Name: Z-0522-2018 Ingenuity TF PET/CT - a integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography...
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2017-11-01
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2017-11-01 / Terminated / root cause: supplier

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of Ingenuity TF PET/CT - a integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) system on 2017-11-01. FDA classified it as Class II and gives the reason as "One of the two wire channels mounted inside the Gantry Separation Unit (GSU) that is also used to secure the top two GSU covers, was missing mounting hardware". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as supplier.

Recall record

Recall number: Z-0522-2018
Classification: Class II
Status: Terminated
Initiated: 2017-11-01
Posted: 2018-02-04
Terminated: 2018-08-14
Recalling firm: Philips North America LLC
Product: Ingenuity TF PET/CT - a integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) system
Product code: KPS System, Tomography, Computed, Emission
Reason for recall: One of the two wire channels mounted inside the Gantry Separation Unit (GSU) that is also used to secure the top two GSU covers, was missing mounting hardware.
Root cause tag: supplier
FDA root cause: Vendor change control
Action: Philips Healthcare is notifying the affected users of this issue via this Customer Information Letter and correcting via Field Change Order FC088200514.
Quantity in commerce: 2
Distribution: One domestic and 1 foreign consignee ( Spain)
Product codes and lots: Ingenuity TF PET/CT Model # 882442

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0522-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0522-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-14	2018-02-04

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)