FDA Medical Device Recalls (openFDA)
Philips Medical Systems (Cleveland) Inc: Philips Healthcare Brilliance iCT SP computed tomography x-ray system
- Recall number
- Z-0332-2018
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Product
- Philips Healthcare Brilliance iCT SP computed tomography x-ray system
- Status
- Terminated
- Initiated
- 2017-11-08
- Posted
- not on file
- Terminated
- 2020-04-17
- Reason
- There is a possibility that screws holding an internal portion of the gantry (Reaction Ring) to the scanner s main bearing may come loose. If this occurs, the part(s) will not be expelled, however, a noise may be heard coming from the gantry.
- Root cause
- Device Design
- Action
- Philips Healthcare is informing consignees of this issue through a Customer Information Letter (CIL_FCO72800690). Philips Key Market representatives will distribute the letter internationally, based on local regulations. Additionally, a Field Service Engineer will contact each site to schedule a time to implement the Field Change Order. Customers are notified that if they hear an unusual noise coming from the gantry, or scan halts, the Philips representative should be contacted as soon as possible. Philips will be inspecting the affected systems, tightening and replacing the reaction ring screws as needed at no additional cost.
- Quantity
- 134
- Distribution
- 107 domestic accounts 15 US Govt accounts 682 Foreign Accounts 3 Mexico accounts 12 Canada accounts
- Lot, serial or model codes
- Brilliance iCT SP - 728311 Devices manufactured 03/05/2009 to present.
- 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