Brilliance iCT Heavyweight Gantry Scanner, M/N 728306, S/N: 100016, 100018 -100025 The Brilliance iCT is a Computed Tomo

FDA device recall Z-2460-2010 · posted 2010-09-22 · Terminated

Recall details

Recalling firm

Philips Medical Systems (Cleveland) Inc

Reason for recall

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

Action taken

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).

Root cause

Other

Status

Terminated

Product code

JAK

Quantity affected

9 units

Distribution

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

Date initiated

2010-04-14

Date posted

2010-09-22

Date terminated

2012-09-24

Location

Cleveland, OH

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