Philips Medical Systems (Cleveland) Inc: Medical Device Recall in 2015 - (Recall #: Z-2204-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: March 17, 2015

Date Posted: July 29, 2015

Recall Number: Z-2204-2015

Event ID: 71227

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.

Status: Terminated

Product Quantity: 55 units

Code Information:

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.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated