FDA Medical Device Recalls (openFDA)
Philips Medical Systems (Cleveland) Inc: 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.
- Recall number
- Z-2460-2010
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- 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.
- Status
- Terminated
- Initiated
- 2010-04-14
- Posted
- 2010-09-22
- Terminated
- 2012-09-24
- Reason
- 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
- Other
- Action
- 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).
- Quantity
- 9 units
- Distribution
- Worldwide Distribution - USA, including the states: DC, GA, IL, IN, NY and OH; and the countries of Germany and the Netherlands.
- Lot, serial or model codes
- M/N 728306, S/N: 100016, 100018 - 100025
- 510(k) numbers
- K060937
- PMA numbers
- not on file
- Product code
- JAK
- Firm FEI
- 1525965
- Firm city
- Cleveland
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- 3e6df46828c1
- Size
- 288213574 bytes
- Published
- 2026-10-06
- Read
- 2026-10-07T03:20:25.099Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-14
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 3e6df46828c1, published 2026-10-06