FDA Medical Device Recalls (openFDA)
Philips Medical Systems (Cleveland) Inc: Brilliance 64, Computed Tomography X-Ray System, Model Numbers: 728231 and 728326, including the Ingenuity CT. The recalled units are equipped with software versions: 3.5.21028 and 3.5.25028. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
- Recall number
- Z-2206-2011
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Product
- Brilliance 64, Computed Tomography X-Ray System, Model Numbers: 728231 and 728326, including the Ingenuity CT. The recalled units are equipped with software versions: 3.5.21028 and 3.5.25028. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
- Status
- Terminated
- Initiated
- 2011-03-07
- Posted
- 2011-05-19
- Terminated
- 2013-02-22
- Reason
- A program software error in the algorithm produces image artifacts that could possibly lead to a misdiagnosis of patients who have small metal implants.
- Root cause
- Other
- Action
- A 'Field Safety Notice - Urgent - Medical Device Correction' notification was sent to the firm's customers via Certified mail on 3/8/2011. The notification letter explains the nature of the Metal Artifact Reduction/Metal Artifact Correction software error; the Brilliance CT X-Ray systems subject to correction and how to identify them; and the circumstances under which this error can occur. It also asks that the user stop running the MAR application on any of the affected Brilliance systems identified with the recalled serial numbers and software versions alluded to in the medical device correction notification. Lastly, the notification states that Philips Medical will provide a solution that will fix the issue and the notification lists contact names; telephone numbers; and E-mail addresses which the customer can contact for further information concerning this device issue, or customer support assistance.
- Quantity
- 10 units
- Distribution
- Nationwide Distribution -- DC, IL, IN, MI, MO, NY, OH, OR, PA, TX, and VT.
- Lot, serial or model codes
- The following Serial Numbers of the Brilliance 64 (including Ingenuity CT) are subject to recall/software correction: 4003, 9745, 9875, 90135, 90169, 95414, 300003, 300004, 300005, and 300010.
- 510(k) numbers
- ["K033326"]
- 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