Z-2257-2015Class II

Computed Tomography X-ray Systems Ingenuity Core. Intended to produce cross-sectional images of the body by...

Name: Z-2257-2015 Computed Tomography X-ray Systems Ingenuity Core. Intended to produce cross-sectional images of the body by...
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2015-02-05
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2015-02-05 / Terminated / root cause: software

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of Computed Tomography X-ray Systems Ingenuity Core. Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data... on 2015-02-05. FDA classified it as Class II and gives the reason as "5 issues. Fast Get Ready incorrectly enabled during service procedures. Contrast annotation missing for some images when manual contrast was administered. Dot artifact present, intermittently, after startup. Heart Rate...". 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-2257-2015
Classification: Class II
Status: Terminated
Initiated: 2015-02-05
Posted: 2015-07-24
Terminated: 2018-06-26
Recalling firm: Philips North America LLC
Product: Computed Tomography X-ray Systems Ingenuity Core. Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: 5 issues. Fast Get Ready incorrectly enabled during service procedures. Contrast annotation missing for some images when manual contrast was administered. Dot artifact present, intermittently, after startup. Heart Rate measured value incorrectly remains constant for some heart rate change conditions. DoseRight incorrectly enabled when the Exam Card specified disabling DoseRight. Tube heat predict
Root cause tag: software
FDA root cause: Software change control
Action: On 2/5/2015 the firm sent Customer Information Letters to their customers.
Quantity in commerce: 82 units
Distribution: Worldwide Distribution-US (nationwide) including the states of AR, AZ, CA, CT, DE, FL, GA, IA, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NH, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VT, WV & WY, and to the following countries: Argentina, Australia, Austria, Belgium, Bolivia, Brazil, Cambodia, Canada, China, Colombia, Denmark, Finland, France, Germany, Hong Kong, India, Indonesia, Iran, Iraq, Ireland, Italy, Japan, Latvia, Libyan Arab Jamahiriya, Lithuania, Malaysia, Mexico, Myanmar, Netherlands, New Zealand, Norway, Panama, Philippines, Russia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uzbekistan & Viet Nam.
Product codes and lots: Model #728321; Serial #s: 31001, 52007, 52008, 52010, 52012, 52013, 52018, 52020, 52021, 52024, 52026, 52030, 52031, 52032, 52033, 52034, 52035, 52036, 52037, 52038, 52039, 52042, 52043, 52046, 52052, 52053, 52054, 52055, 52057, 52058, 310001, 310002, 310003, 310009, 310017, 310052, 310055, 310059, 310064, 310069, 310070, 310071, 310081, 310087, 310088, 310096, 310111, 310113, 310119, 310121, 310129, 310133, 310134, 310141, 310143, 310144, 310149, 310151, 310157, 310160, 310170, 333002, 333009, 333014, 333015, 333030, 333031, 333037, 333042, 333043, 333044, 333045, 333046, 333051, 333052, 333053, 333055, 333056, 333057, 333059, 333060 & 333061.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2257-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2254-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-05	2015-07-24
Z-2255-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-05	2015-07-24
Z-2256-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-05	2015-07-24
Z-2257-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-05	2015-07-24
Z-2258-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-05	2015-07-24
Z-2259-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-05	2015-07-24

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)