Philips Medical Systems (Cleveland) Inc: Medical Device Recall in 2015 - (Recall #: Z-2205-2015)

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 CT Computed Tomography X-ray Systems

Product Classification:

Class II

Date Initiated: March 17, 2015

Date Posted: July 29, 2015

Recall Number: Z-2205-2015

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 CT, which was shipped with this system.

Status: Terminated

Product Quantity: 66 units

Code Information:

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.

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