Z-2914-2011

Vertical Brake Hubs component of the Philips MX8000 Series Dual v. Exp. Computed Tomography System, Serial...

Name: Z-2914-2011 Vertical Brake Hubs component of the Philips MX8000 Series Dual v. Exp. Computed Tomography System, Serial...
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2011-06-03
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2011-06-03 / Terminated / root cause: design

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of Vertical Brake Hubs component of the Philips MX8000 Series Dual v. Exp. Computed Tomography System, Serial Numbers: 8008-8413, 80001-800022, Model #728130, 510... on 2011-06-03. The reason FDA records is "Philips Medical Systems decided to conduct a recall/field correction of the patient support vertical brake hub component in all of their CT MX8000 Dual v. Exp Computed Tomography X-Ray System scanners due to a component...". 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-2914-2011
Status: Terminated
Initiated: 2011-06-03
Posted: 2011-08-01
Terminated: 2013-08-07
Recalling firm: Philips North America LLC
Product: Vertical Brake Hubs component of the Philips MX8000 Series Dual v. Exp. Computed Tomography System, Serial Numbers: 8008-8413, 80001-800022, Model #728130, 510 (k) #K010817. Product Usag: The MX 8000 series Dual v. Exp are Computed Tomography X-Ray system units 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: KPS System, Tomography, Computed, Emission
Reason for recall: Philips Medical Systems decided to conduct a recall/field correction of the patient support vertical brake hub component in all of their CT MX8000 Dual v. Exp Computed Tomography X-Ray System scanners due to a component defect which could cause an unexpected downward motion of the table (couch) while the patient is on the table. This event could occur because the short key connecting the vertical
Root cause tag: design
FDA root cause: Device Design
Action: Philips Medical Systems (Cleveland) Inc. issued an "URGENT - Medical Device Correction - Field Safety Notice" letter dated June 1, 2011 to all affected customers, via Certified Mail for tracking purposes. The notification identified the product, the problem involved, and the action(s) to be taken by the customers with regard to this device issue. The notification instructs the customers to monitor their units and if the recalled product malfunctions, to immediately notify their Phillips service representative. The letter also states that a Philips Field Service Engineer will visit each customer location and perform a brake repair or replacement on their system to resolve the issue. For further information or support, the customers are instructed to contact their local Philips representative or local Philips Healthcare office. For North America and Canada the customers are instructed to contact the Customer Care Solutions Center (1-800-722-9377, option 5: Enter Site ID or follow the prompt(s).
Quantity in commerce: 412 system units were distributed.
Distribution: Worldwide Distribution -- USA (nationwide) including the states of: AR, AZ, CA, CO, FL, FA, HI, IL, IN, KY, MA, MI, MO, MS, NC, NV, NY, OH, OK, SC, SD, TN, TX, VA, VT, WA and Puerto Rico and the country of Canada.
Product codes and lots: The following Serial Numbers of the CT X-ray Scanners are subject to recall/correction: 8008-8413, 80001-800022.

Product code KPS

K010817Class IIMx8000 V5.0 CT SystemPhilips Medical Systems (Cleveland), Inc. / cleared 2001-06-15

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)