Z-2115-2016Class II

Ingenuity Core, model # 728326; Intended to produce cross- sectional images of the body

Name: Z-2115-2016 Ingenuity Core, model # 728326; Intended to produce cross- sectional images of the body
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2016-06-21
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2016-06-21 / Terminated / root cause: manufacturing process

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of Ingenuity Core, model # 728326; Intended to produce cross- sectional images of the body on 2016-06-21. FDA classified it as Class II and gives the reason as "Supplier design change contributed to a thinner plastic which was used as part of the cover on the devices. The thinner plastic cover may crack causing injury to patients, operators, by-standers and service personnel". 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-2115-2016
Classification: Class II
Status: Terminated
Initiated: 2016-06-21
Posted: 2016-06-30
Terminated: 2018-07-02
Recalling firm: Philips North America LLC
Product: Ingenuity Core, model # 728326; Intended to produce cross- sectional images of the body.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: Supplier design change contributed to a thinner plastic which was used as part of the cover on the devices. The thinner plastic cover may crack causing injury to patients, operators, by-standers and service personnel.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Philips is informing the consignee of this issue through: Customer Information Letter (CIL) 72800656 . International consignees will be contacted by Philips Healthcare Global Market representatives, who will distribute the CIL. A Field Service Engineer (FSE) will contact the customers to schedule a time to conduct the appropriate correction through Field Change Order (FCO) 72800656 once it is available. This FCO will address the above identified issue. A response form sent to the customer via certified mail. This package will also contain a return receipt.
Quantity in commerce: 1 unit
Distribution: Distributed in China, Denmark, Germany, Hungary, Italy, Philippines, Spain, Sweden, Switzerland, Thailand, and United Kingdom.
Product codes and lots: 901510

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2115-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2111-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-06	2016-06-30
Z-2112-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-06	2016-06-30
Z-2113-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-06	2016-06-30
Z-2114-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-06	2016-06-30
Z-2115-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-06	2016-06-30

Product code JAK

K033326Class IIPhilips Plus Computed Tomography SystemPhilips Medical Systems, Inc. / cleared 2003-10-29

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)