FDA Medical Device Recalls (openFDA)
Philips Medical Systems (Cleveland) Inc: Brilliance iCT - Model #728306, and Brilliance iCT SP - Model #728311, CT Scanning System is subject to recall/correction Product Usage: The Brilliance 6, 16, 40 64, Brilliance Big Bore, iCT, iCT SP and Ingenuity CT are Computed Tomography X-Ray Systems that are intended to produce cross-sectional images of the body by computer reconstruction of X-Ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment , patient, and equipment supports, components and accessories.
- Recall number
- Z-1693-2012
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Product
- Brilliance iCT - Model #728306, and Brilliance iCT SP - Model #728311, CT Scanning System is subject to recall/correction Product Usage: The Brilliance 6, 16, 40 64, Brilliance Big Bore, iCT, iCT SP and Ingenuity CT are Computed Tomography X-Ray Systems that are intended to produce cross-sectional images of the body by computer reconstruction of X-Ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment , patient, and equipment supports, components and accessories.
- Status
- Terminated
- Initiated
- 2012-03-26
- Posted
- 2012-05-30
- Terminated
- 2013-02-22
- Reason
- Component defect. Following their receipt of a customer complaint, Philips Medical determined that the metal blocks which support the scissor slide rails underneath the scanning table (couch) of several of the firm's CT scanning systems were not manufactured to specification and may crack.
- Root cause
- Nonconforming Material/Component
- Action
- Philips issued an 'URGENT Medical Device Correction' letter dated March 27, 2012 to all affected customers. The letter identified the affected products, problem, hazard involved, how to identify affected products, and actions to be taken by customer/user. The letter informed customers that Philips intends to dispatching service personnel to each customer site in order to correct this issue. In the meantime, the letter recommend customer to contact their Philips representative if they hear unusual noises when moving the couch vertically, or if there is unintended vertical motion of the couch. For questions contact your local Philips representative or local Philips Healthcare office. For North America and Canada contact the Customer Care Solutions Center 1-800-722-9377, option 5: Enter Site ID or follow the prompts.
- Quantity
- 3 units were distributed in the U.S.
- Distribution
- Worldwide Distribution - U.S. (Nationwide) including the states of: CA, FL,, HI, IA, IN, KY, LA, MA,, MI, MO, MS. NM, NV, OH, PA, PA, SC, TN, TX, WA, and Puerto Rico
- Lot, serial or model codes
- Serial Numbers: 100165, 100193, 200041
- 510(k) numbers
- ["K012009","K033326","K033357","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