Z-2496-2018Class II

Ingenuity Digital PET/CT System, Model 882446 with the following UDI's: (01)00884838059559(21)900004...

Name: Z-2496-2018 Ingenuity Digital PET/CT System, Model 882446 with the following UDI's: (01)00884838059559(21)900004...
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2018-05-21
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2018-05-21 / Terminated / root cause: software

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of Ingenuity Digital PET/CT System, Model 882446 with the following UDI's: (01)00884838059559(21)900004 (01)00884838059559(21)900005 (01)00884838059559(21)900006... on 2018-05-21. FDA classified it as Class II and gives the reason as "The block used to connect the patient pallet to the couch may be assembled incorrectly. A screw may be misaligned in the patient pallet". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2496-2018
Classification: Class II
Status: Terminated
Initiated: 2018-05-21
Posted: 2018-07-19
Terminated: 2020-04-10
Recalling firm: Philips North America LLC
Product: Ingenuity Digital PET/CT System, Model 882446 with the following UDI's: (01)00884838059559(21)900004 (01)00884838059559(21)900005 (01)00884838059559(21)900006 (01)00884838059559(21)900007 (01)00884838059559(21)900008 (01)00884838059559(21)900009 (01)00884838059559(21)900010 (01)00884838059559(21)900011 (01)00884838059559(21)900012 (01)00884838059559(21)900013 (01)00884838059559(21)900014 (01)00884838059559(21)900015 (01)00884838059559(21)900016 (01)00884838059559(21)900017 (01)00884838059559(21)900018 (01)00884838059559(21)900019 (01)00884838059559(21)900020 (01)00884838059559(21)900021 (01)00884838059559(21)900022 (01)00884838059559(21)900023 (01)00884838059559(21)900024 (01)00884838059559(21)900025 (01)00884838059559(21)900026 (01)00884838059559(21)900027 (01)00884838059559(21)900028 (01)00884838059559(21)900029 (01)00884838059559(21)900030 (01)00884838059559(21)900031 (01)00884838059559(21)900032 (01)00884838059559(21)900033 (01)00884838059559(21)900034 (01)00884838059559(21)900035 Product Usage: The system is intended to image the whole body, heart, brain, lung, gastrointestinal, bone, lymphatic, and other major organs for a wide range of patient types, sizes, and extent of diseases. Both subsystems can also be operated as fully functional, independent diagnostic tools, including application of the CT scanner for diagnosis and for use in radiation therapy planning.
Product code: KPS System, Tomography, Computed, Emission
Reason for recall: The block used to connect the patient pallet to the couch may be assembled incorrectly. A screw may be misaligned in the patient pallet.
Root cause tag: software
FDA root cause: Software design
Action: On May 21, 2018, Philips issued Customer Information notices to their clients. A Philips Field Service Engineer will contact customers directly to schedule the updates at your specific site. If you need any further information or support concerning this issue, please contact your local Philips representative. For SUPPORT in North America and Canada, contact the Customer Care Solutions Center 1-800-722-9377, follow prompts.
Quantity in commerce: 32 units
Distribution: Worldwide Distribution - US Nationwide in the states of CA, GA, LA, MD, MI, NY, OH, TN, TX, VT, Washington DC & WI Internationally - Canada, Mexico, Belgium, France, Israel, Luxembourg, Netherlands, Singapore, Spain & Switzerland
Product codes and lots: Serial Numbers: 900004 900005 900006 900007 900008 900009 900010 900011 900012 900013 900014 900015 900016 900017 900018 900019 900020 900021 900022 900023 900024 900025 900026 900027 900028 900029 900030 900031 900032 900033 900034 900035

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2496-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2496-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-25	2018-07-19

Product code KPS

K123599Class IIIngenuity Digital Pet/ctPhilips Healthcare (Cleveland) / cleared 2013-07-12

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)