—#136855

Product

Head Holder shipped with Ingenuity Core 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.

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K033326
Affected lot / code info: Head Holder M/N 4535 671 11331. Ingenuity Core - M/N 728321, Serial #s: 7725, 10614, 10663, 50171, 95735, 300072, 310001, 310006, 310008, 310009, 310010, 310012, 310013, 310014, 310015, 310017, 310018, 310020, 310021, 310022, 310024, 310025, 310026, 310028, 310029, 310030, 310031, 310032, 310033, 310034, 310035, 310037, 310038, 310039, 310040, 310041, 310042, 310043, 310044, 310045, 310046, 310047, 310048, 310049, 310050, 310051, 310052, 310053, 310054, 310055, 310056, 310057, 310058, 310059, 310060, 310061, 310062, 310063, 310064, 310065, 310066, 310067, 310068, 310069, 310070, 310071, 310072, 310073, 310074, 310075, 310076, 310077, 310078, 310079, 310080, 3100016, EP16E110078, EP16E120020 & EP16ER110018.

Why it was recalled

A head holder released for use with other CT systems but not yet qualified for use on the Ingenuity Core, which was shipped with this system.

Root cause (FDA determination)

Mixed-up of materials/components

Action the firm took

On 6/4/2015, the firm mailed Customer Information Letters.

Recalling firm

Firm: Philips Medical Systems (Cleveland) Inc
Address: 595 Miner Rd, Cleveland, Ohio 44143-2131

Distribution

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.

Timeline

Recall initiated: 2015-03-17
Posted by FDA: 2015-07-22
Terminated: 2018-06-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #136855. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.