Philips Medical Systems (Cleveland) Inc: 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.

Recall number

Z-2914-2011

Recalling firm

Philips Medical Systems (Cleveland) Inc

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.

Status

Terminated

Initiated

2011-06-03

Posted

2011-08-01

Terminated

2013-08-07

Reason

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

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

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.

Lot, serial or model codes

The following Serial Numbers of the CT X-ray Scanners are subject to recall/correction: 8008-8413, 80001-800022.

510(k) numbers

["K010817"]

PMA numbers

not on file

Product code

KPS

Firm FEI

1525965

Firm city

Cleveland

Firm state

OH

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

Copy