FDA Medical Device Recalls (openFDA)
Philips Medical Systems (Cleveland) Inc: Brilliance iCT
- Recall number
- Z-1058-2017
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Product
- Brilliance iCT
- Status
- Terminated
- Initiated
- 2016-12-23
- Posted
- not on file
- Terminated
- 2018-06-26
- Reason
- During a retrospective review of production documentation it was observed that the M6 Rotor Counterweight Bolt may have been improperly torqued.
- Root cause
- Employee error
- Action
- Philips sent an Customer Information letter. A document showed an incorrect torque wrench used during the assembly process which could potentially apply 4 Newton-meters less torque than specified to the system rotor counterweight bolts. Out of an abundance of caution, Philips will have a Field Service Engineer ensure the bolts on your system are correctly torqued. If you need any further information or support concerning this issue, please contact your local Philips representative. For further information please call (440) 483-5777.
- Quantity
- 1-unit
- Distribution
- Product was not distributed in the US. Unit was distributed in Australia.
- Lot, serial or model codes
- Rotor-4535-673-94382 SN 19, installed on Brilliance ICT System S/N 200203
- 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
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28