Recalls / —

—#137882

Product

Head Holder shipped with Ingenuity CT Computed Tomography X-ray Systems

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 CT M/N 728326, Serial #s: 6617, 10607, 10689, 32000, 300043, 300064, 300068, 300071, 300072, 300073, 300074, 300075, 300076, 300077, 300078, 300079, 300080, 300081, 300082, 300084, 300085, 300086, 300087, 300088, 300089, 300091, 300092, 300093, 300094, 300095, 300096, 300097, 300098, 300099, 300100, 300101, 300102, 300103, 300104, 300105, 300106, 300107, 300108, 300109, 300110, 300111, 300112, 300113, 300114, 300116, 300117, 300118, 300119, 300120, 300121, 300122, 300123, 300124, 300125, 300126, 300127, 300128, 300129, 300130, 300131 & 300132.

Why it was recalled

A head holder released for use with other CT systems but not yet qualified for use on the Ingenuity CT, 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 #137882. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.