Z-2204-2015Class II

Head Holder shipped with Ingenuity Core 128 Computed Tomography X-ray Systems. Intended to produce...

Name: Z-2204-2015 Head Holder shipped with Ingenuity Core 128 Computed Tomography X-ray Systems. Intended to produce...
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2015-03-17
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2015-03-17 / Terminated

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of Head Holder shipped with Ingenuity Core 128 Computed Tomography X-ray Systems. Intended to produce cross-sectional images of the body by computer... on 2015-03-17. FDA classified it as Class II and gives the reason as "A head holder released for use with other CT systems but not yet qualified for use on the Ingenuity Core 128, which was shipped with this system". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2204-2015
Classification: Class II
Status: Terminated
Initiated: 2015-03-17
Posted: 2015-07-22
Terminated: 2018-06-26
Recalling firm: Philips North America LLC
Product: Head Holder shipped with Ingenuity Core 128 Computed Tomography X-ray Systems. 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: A head holder released for use with other CT systems but not yet qualified for use on the Ingenuity Core 128, which was shipped with this system.
FDA root cause: Mixed-up of materials/components
Action: On 6/4/2015, the firm mailed Customer Information Letters.
Quantity in commerce: 55 units
Distribution: Worldwide Distribution-Product was shipped to the following states: AR, AR, AZ, CA, CO, CT, FL, GA, IA, IN, KS, LA, MA, MD, MI, MO, MS, NC, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, VA, VT, WA, WV & WY, and to the following countries: Argentina, Australia, Bangladesh, Belgium, Brazil, Bulgaria, China, Colombia, Denmark, Ecuador, France, Germany, India, Indonesia, Israel, Japan, Latvia, Libya, Myanmar, Norway, Oman, Poland, Republic of Korea, Russian Federation, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom & Viet Nam.
Product codes and lots: Head Holder M/N 4535 671 11331. Ingenuity Core 128 - M/N 728323, Serial #s: 300068, 320003, 320004, 320005, 320006, 320007, 320008, 320009, 320010, 320011, 320013, 320014, 320015, 320017, 320018, 320019, 320020, 320021, 320022, 320023, 320024, 320025, 320026, 320027, 320028, 320029, 320030, 320031, 320032, 320033, 320034, 320035, 320036, 320037, 320038, 320040, 320041, 320042, 320043, 320044, 320045, 320046, 320047, 320048, 320049, 320050, 320052, 320053, 320054, 320055, 320056, 320057, 320058, 320059 & EP16E110092.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2204-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2203-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-22
Z-2204-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-22
Z-2205-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-22

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)