FDA Medical Device Recalls (openFDA)
Philips North America, LLC: Philips Brilliance IQon Spectral CT, Computed Tomography X-Ray System; Model # 728332; UDI # (01)00884838059542(21)860067
- Recall number
- Z-1923-2020
- Recalling firm
- Philips North America, LLC
- Product
- Philips Brilliance IQon Spectral CT, Computed Tomography X-Ray System; Model # 728332; UDI # (01)00884838059542(21)860067
- Status
- Terminated
- Initiated
- 2020-04-06
- Posted
- 2020-05-06
- Terminated
- 2022-09-16
- Reason
- The bolt affixing the cooling unit to the rotor was not tightened to specification on the Philips Brilliance iCT systems.
- Root cause
- Process control
- Action
- Philips sent a Medical Device Correction-Urgent Field Safety Notice dated April 6, 2020 to all affected customers. The firm instructed customers to review the information with all members of the staff who need to be aware of the contents of the notice and to maintain a copy with the equipment in the Instructions for Use. Customers were directed to complete and return the form stating that they received, read, and understood the contents of the letter and have taken appropriate actions. URGENT - Field Safety Notice Medical Device Correction letter dated 5/20/20 was sent to customers informing them of two additional affected systems. There is no action required by the customer. Testing and engineering analysis demonstrate that the under-torqued bolts do not pose any immediate safety risk as the mechanical connection between the cooling unit and the rotor continues to meet applicable safety standards. The affected systems may continue to be used according to the IFU. Philips is distributing this FSN to all affected customers/users and will correct the issue via Field Change Order FCO 72800725. Urgent Field Safety Notice Medical Device Correction dated 5/20/20 was distributed to notify additional systems not previously included in the original notification. There is no action required by the customer. Testing and engineering analysis demonstrate that the under-torqued bolts do not pose any immediate safety risk as the mechanical connection between the cooling unit and the rotor continues to meet applicable safety standards. The affected systems may continue to be used according to the IFU. Philips is distributing this FSN to all affected customers/users and will correct the issue via Field Change Order FCO 72800725. If you need any further information or support concerning this issue, please contact your local Philips representative: For North America, contact the Customer Care Solutions Center (1-800-722-9377, follow the prompts).
- Quantity
- 2
- Distribution
- Worldwide distribution including one unit distributed to Iowa.
- Lot, serial or model codes
- Serial #s 860067, 860023
- 510(k) numbers
- ["K193454"]
- PMA numbers
- not on file
- Product code
- JAK
- Firm FEI
- 1218950
- Firm city
- Andover
- Firm state
- MA
- 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