—#129682

Product

Brilliance CT System 6/10/16/16P/40 configuration. No packaging, sold as single unit. Computed tomography scanner intended to provide cross sectional images of the human body and visualization of the internal organs.

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K010817, K033326
Affected lot / code info: 728256, 728251, 728246, 728240, and 728235.

Why it was recalled

The system has a gap that can appear between the upper and lower tilt stand covers. The fingers may be squeezed if a person was to place them in this region while the gantry was tilting from an angle to zero tilt angle.

Root cause (FDA determination)

Device Design

Action the firm took

Customers will be contacted by a field service technician with the field correction order. The firm will install the new labeling to the device.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution -- AZ, CO, GA, IA, IL, IN, KS, KY, MD, MI, MN, MS, NC, NY, OH, OK, TX, VT, and WI; and, countries of Singapore, New Zealand, India, Australia, Korea, Japan, Korea, China, India, Taiwan, Australia, Turkey, France, South Africa, Spain, Italy, Austria, Belgium, Switzerland, Israel, Netherlands, England, and Brazil.

Timeline

Recall initiated: 2005-12-27
Posted by FDA: 2014-09-26
Terminated: 2015-11-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #129682. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.