Z-2275-2018Class II

Ingenuity Core128 728323

Name: Z-2275-2018 Ingenuity Core128 728323
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2018-03-28
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2018-03-28 / Terminated / root cause: manufacturing process

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of Ingenuity Core128 728323 on 2018-03-28. FDA classified it as Class II and gives the reason as "A problem has been detected in the X-Ray Tube. The affected tubes have a production defect that allows oil leakage from the tube housing, if it were to re-occur, could pose a risk for patients or users". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2275-2018
Classification: Class II
Status: Terminated
Initiated: 2018-03-28
Posted: 2018-06-22
Terminated: 2020-04-21
Recalling firm: Philips North America LLC
Product: Ingenuity Core128 728323
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: A problem has been detected in the X-Ray Tube. The affected tubes have a production defect that allows oil leakage from the tube housing, if it were to re-occur, could pose a risk for patients or users.
Root cause tag: manufacturing process
FDA root cause: Other
Action: Urgent Field Safety Notice letters were sent to customers on 3/28/18. The letters did not request any actions to be conducted by the customers. For Brilliance Big Bore/ Ingenuity CT / Ingenuity Core / Ingenuity Corel 28 Customers: A Philips Field Service Engineer will contact you to schedule the FCO updates at your site. Field Change Order (FCO 72800691 and 72800692) will be released to correct the issue. For Ingenuity TF PET/CT Customers: Field Change Order (FCO 88200520 and 88200511) will be released to correct this issue. A Philips Field Service Engineer will contact you to schedule the FCO updates at your site.
Quantity in commerce: 28 total
Distribution: The systems were distributed to the following US states: HI, KS, and MO. The systems were distributed to the following foreign countries: Algeria, Austria, Brazil, China, Indonesia, Japan, Kenya, Korea, Mexico, Poland, Turkey, and Uganda.
Product codes and lots: UDI: (01)00884838059504(21)320403, Serial Number: 320403; UDI: (01)00884838059504(21)320405, Serial Number: 320405; UDI: (01)00884838059504(21)320406, Serial Number: 320406; UDI: (01)00884838059504(21)336321, Serial Number: 336321; UDI: (01)00884838059504(21)320411, Serial Number: 320411; UDI: (01)00884838059504(21)336323, Serial Number: 336323; UDI: (01)00884838059504(21)320425, Serial Number: 320425; Serial Number: 320122

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2275-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2273-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-04	2018-06-22
Z-2274-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-04	2018-06-22
Z-2275-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-04	2018-06-22
Z-2276-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-04	2018-06-22
Z-2277-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-04	2018-06-22

Product code JAK

K160743Class IIPhilips Ingenuity CTPhilips Medical Systems (Cleveland), Inc. / cleared 2016-08-08

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)