Philips Brilliance 6, 16, 40, 64, Big Bore, iCT and iCT SP are Computed Tomography X-Ray Systems. The devices are Comput

FDA device recall Z-2035-2012 · posted 2012-07-19 · Terminated

Recall details

Recalling firm

Philips Medical Systems (Cleveland) Inc

Reason for recall

Philips Healthcare was notified that several of the sixteen bolts securing the brackets which support the carbon table top on various models of their Brilliant CT scanner have been found to be defective and the bolt heads may break off.

Action taken

Philips sent a Urgent Medical Device Correction letter dated June 28, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Philips Key Market representatives will distribute the letter internationally. Additionally, a Field Service Engineer will visit each site to inspect and correct the issue, and Philips will be tracking the progressof the correction. For further information, Customers were asked to contact their local Philips representative or Philips Healthcare Office. North American and Canadian consignees should contact the Philips Customer Care Solutions Center at 1-800-722-9377

Root cause

Process control

Status

Terminated

Product code

JAK

Quantity affected

524

Distribution

Worldwide Distribution -- USA (nationwide) including the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, MJ, NM, NV, NY, OH, OK, OR, PA, PR, TN, T

Date initiated

2012-07-02

Date posted

2012-07-19

Date terminated

2013-12-24

Location

Cleveland, OH

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