Z-0791-2014Class II

Brilliance iCT, Brilliance 64 and Brilliance Big Bore The Brilliance iCT, Brilliance 64 and Brilliance Big...

Name: Z-0791-2014 Brilliance iCT, Brilliance 64 and Brilliance Big Bore The Brilliance iCT, Brilliance 64 and Brilliance Big...
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2011-03-07
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2011-03-07 / Terminated / root cause: software

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of Brilliance iCT, Brilliance 64 and Brilliance Big Bore The Brilliance iCT, Brilliance 64 and Brilliance Big Bore are Computed Tomography X-Ray Systems intended... on 2011-03-07. FDA classified it as Class II and gives the reason as "The DoseRight feature suggest a mAs based on the measured patient size, a reference size and a reference mAs. When scanning large children, the suggested mAs may be higher than clinicians would expect". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0791-2014
Classification: Class II
Status: Terminated
Initiated: 2011-03-07
Posted: 2014-01-29
Terminated: 2014-04-28
Recalling firm: Philips North America LLC
Product: Brilliance iCT, Brilliance 64 and Brilliance Big Bore The Brilliance iCT, Brilliance 64 and Brilliance Big Bore are Computed Tomography X-Ray Systems 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: The DoseRight feature suggest a mAs based on the measured patient size, a reference size and a reference mAs. When scanning large children, the suggested mAs may be higher than clinicians would expect.
Root cause tag: software
FDA root cause: Software design
Action: Philips Medical Systems sent a Field Safety Notice letter dated February 25, 2011, to all affected customers.The letter identified the product the problem and the action needed to be taken by the customers. Your Corrective Action Plan (CAP) is approved and consists of: 1. Notifying all affected users with Field Safety Notice 72800527/72800528 starting March 8, 2011. This Field Safety Notice has been reviewed and is approved. 2. Following up with all responses by dispatching a Field Service engineer to each site to install the software update at no cost to the user. 3. Tracking the responses from users by certified mail. For further questions please call (440) 483-7600.
Quantity in commerce: 23
Distribution: Worldwide Distribution - US Distribution including the states of DC, IL, IN, MI, MO, NY, OH, OR, PA, TX and VT., and the countries of Australia, Belgium, China, Germany, India, Israel, Italy and The Netherlands.
Product codes and lots: Brilliance iCT: Model Number 728311 and 728306, Serial Number: 100103, 100019, 100023, 100170, 200047, 200013 200005 and 100087. Brilliance 64: Model Number 728231 and 728326, Seial Number: 4003, 9745, 9875, 90135, 90169, 95414, 300003, 300004, 300005 and 300010. Brilliance CT Big Bore, Model Number: 728243, Serial Number: 7006, 7060, 7154, 7298 and 7349.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0791-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0791-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-05	2014-01-29

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)