—#93823

Product

Brilliance iCT Heavyweight Gantry Scanner, M/N 728306, S/N: 100016, 100018 -100025 The Brilliance iCT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K060937
Affected lot / code info: M/N 728306, S/N: 100016, 100018 - 100025

Why it was recalled

The gantry covers of the iCT have a latch at the base of the system which holds the cover in the closed position. During the course of maintenance the CT Field Service Engineer (FSE) will activate this latching mechanism which in turn has a potential to penetrate the insulation on cabling which carries 277 VAC. If the latch does come into contact with the cabling there is a potential that the FS

Root cause (FDA determination)

Other

Action the firm took

Philips Healthcare sent an URGENT - Field Safety Notice letter, dated April 14, 2010, to their customers notifying them of the product, the problem, and the action to be taken. The letter asked them to identify the affected product by checking for the serial number tag (s/n 10016 10025), ensure that the electrical power was shut-down before opening or closing the gantry cover to prevent potential of an electrical shock, and that a Field Service Engineer would contact the facility to make arrangements for the implementation of a Field Change Order (FCO) before December to correct the problem. For further information or support concerning this issue, the customer was instructed to contact their Philips representative: Customer Care Center (1-800-722-9377, option 5 or their local Philips Healthcare Office).

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution - USA, including the states: DC, GA, IL, IN, NY and OH; and the countries of Germany and the Netherlands.

Timeline

Recall initiated: 2010-04-14
Posted by FDA: 2010-09-22
Terminated: 2012-09-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #93823. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.