Z-1693-2012

Brilliance iCT - Model #728306, and Brilliance iCT SP - Model #728311, CT Scanning System is subject to...

Name: Z-1693-2012 Brilliance iCT - Model #728306, and Brilliance iCT SP - Model #728311, CT Scanning System is subject to...
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2012-03-26
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2012-03-26 / Terminated / root cause: manufacturing process

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of Brilliance iCT - Model #728306, and Brilliance iCT SP - Model #728311, CT Scanning System is subject to recall/correction Product Usage: The Brilliance 6, 16... on 2012-03-26. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1693-2012
Status: Terminated
Initiated: 2012-03-26
Posted: 2012-05-30
Terminated: 2013-02-22
Recalling firm: Philips North America LLC
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.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: 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 tag: manufacturing process
FDA 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 in commerce: 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
Product codes and lots: Serial Numbers: 100165, 100193, 200041

Product code JAK

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)