Z-2709-2014Class II

Brilliance CT System 6/10/16/16P/40 configuration. No packaging, sold as single unit. Computed tomography...

Name: Z-2709-2014 Brilliance CT System 6/10/16/16P/40 configuration. No packaging, sold as single unit. Computed tomography...
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2005-12-27
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2005-12-27 / Terminated / root cause: design

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of Brilliance CT System 6/10/16/16P/40 configuration. No packaging, sold as single unit. Computed tomography scanner intended to provide cross sectional images of... on 2005-12-27. FDA classified it as Class II and gives the reason as "The system has a gap that can appear between the upper and lower tilt stand covers. The fingers may be squeezed if a person was to place them in this region while the gantry was tilting from an angle to zero tilt angle". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2709-2014
Classification: Class II
Status: Terminated
Initiated: 2005-12-27
Posted: 2014-09-26
Terminated: 2015-11-06
Recalling firm: Philips North America LLC
Product: Brilliance CT System 6/10/16/16P/40 configuration. No packaging, sold as single unit. Computed tomography scanner intended to provide cross sectional images of the human body and visualization of the internal organs.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: The system has a gap that can appear between the upper and lower tilt stand covers. The fingers may be squeezed if a person was to place them in this region while the gantry was tilting from an angle to zero tilt angle.
Root cause tag: design
FDA root cause: Device Design
Action: Customers will be contacted by a field service technician with the field correction order. The firm will install the new labeling to the device.
Quantity in commerce: 364
Distribution: Worldwide Distribution -- AZ, CO, GA, IA, IL, IN, KS, KY, MD, MI, MN, MS, NC, NY, OH, OK, TX, VT, and WI; and, countries of Singapore, New Zealand, India, Australia, Korea, Japan, Korea, China, India, Taiwan, Australia, Turkey, France, South Africa, Spain, Italy, Austria, Belgium, Switzerland, Israel, Netherlands, England, and Brazil.
Product codes and lots: 728256, 728251, 728246, 728240, and 728235.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2709-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2709-2014	Class II	Terminated	Voluntary: Firm initiated	2014-10-01	2014-09-25

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)