Z-0693-2012

Ingenuity CT (Computed Tomography) System, 510 (k) #K033326, Model #728326, Serial Numbers: 300005, 300010...

Name: Z-0693-2012 Ingenuity CT (Computed Tomography) System, 510 (k) #K033326, Model #728326, Serial Numbers: 300005, 300010...
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2011-11-11
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2011-11-11 / Terminated / root cause: design

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of Ingenuity CT (Computed Tomography) System, 510 (k) #K033326, Model #728326, Serial Numbers: 300005, 300010, 300011, 300012, 300013, 300014, 300015, 300016... on 2011-11-11. The reason FDA records is "Component defect. When the user is operating the control panel, he/she may inadvertently activate the wrong switch on the control panel which could, in turn, cause the patient couch to move in an unwanted direction". 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-0693-2012
Status: Terminated
Initiated: 2011-11-11
Posted: 2012-01-11
Terminated: 2013-02-22
Recalling firm: Philips North America LLC
Product: Ingenuity CT (Computed Tomography) System, 510 (k) #K033326, Model #728326, Serial Numbers: 300005, 300010, 300011, 300012, 300013, 300014, 300015, 300016, 300017, 300018, 300019, 300020 and 300021. Product Usage: The Ingenuity CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of X-Ray transmission data taken at different angles and planes. This device 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. When the user is operating the control panel, he/she may inadvertently activate the wrong switch on the control panel which could, in turn, cause the patient couch to move in an unwanted direction.
Root cause tag: design
FDA root cause: Device Design
Action: Philips sent an 'URGENT - Medical Device Correction Ingenuity CT' letter dated November 15, 2011. The letter describes the affected product, problem, hazard involved and actions to be taken by the customer and user. In this case, the customers are advised that extra care should be taken when using the 8-way Gantry Panel switch so as to avoid inadvertently activating an unintended switch resulting in unwanted (couch) movement. The letter notifies the customers that a Philips representative will be visiting each customer site and installing a new control panel through a Field Change Order. For further information or support concerning this issue contact your local Philips representative or local Philips Healthcare office. For North America and Canada contact the Customer Care Solutions Center at (1-800-722-9377, option 5; enter site ID or follow prompts).
Quantity in commerce: 13 system units were distributed (5 in U.S. & 8 overseas)
Distribution: Worldwide Distribution - USA (nationwide) in the states of: LA, NY, OH, WV and the foreign countries of: Australia, Germany, Korea, India, Malaysiaa and New Zealand.
Product codes and lots: The following Serial Numbers of this device are subject to recall: Serial Numbers: 300005, 300010, 300011, 300012, 300013, 300014, 300015, 300016, 300017, 300018, 300019, 300020 and 300021.

Product code JAK

K033326Class IIPhilips Plus Computed Tomography SystemPhilips Medical Systems, Inc. / cleared 2003-10-29

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)