Z-0597-2009

Vertical drive brake (on patient supports). Used on certain Philips Medical Systems MX series and Brilliance...

Name: Z-0597-2009 Vertical drive brake (on patient supports). Used on certain Philips Medical Systems MX series and Brilliance...
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2008-09-23
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2008-09-23 / Terminated / root cause: manufacturing process

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of Vertical drive brake (on patient supports). Used on certain Philips Medical Systems MX series and Brilliance series CT scanners. The device is a vertical drive... on 2008-09-23. The reason FDA records is "The product is being recalled because the patient support may travel downwards without being commanded to move". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0597-2009
Status: Terminated
Initiated: 2008-09-23
Posted: 2009-01-16
Terminated: 2012-03-01
Recalling firm: Philips North America LLC
Product: Vertical drive brake (on patient supports). Used on certain Philips Medical Systems MX series and Brilliance series CT scanners. The device is a vertical drive brake that controls the vertical position of a patient support system or couch. The patient support system is intended to be used to place the patient in the correct horizontal and vertical position in order to be scanned. The couch is an accessory product to a computed tomography scanner.
Product code: KPS System, Tomography, Computed, Emission
Reason for recall: The product is being recalled because the patient support may travel downwards without being commanded to move.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: A On 11/15/2007 & 6/6/2008 the firm sent Urgent Device Notification letters to their customers. They notified their customers that a Field Service Engineer will inspect and repair the brake system.
Quantity in commerce: 559
Distribution: Worldwide Distribution: USA including states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI and WV and countries of Argentina, Australia, Austria, Bahamas, Belgium, Brazil, Canada, China, Colombia, Costa Rica, Czech Republic, Denmark, Egypt, England, France, Germany, Greece, China, India, Indonesia, Ireland, Iraq, Italy, Japan, Jordan, Korea, Lebanon, Libya, Lithuania, Malaysia, Malta, Mexico, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Saudi Arabia, South Africa, South Korea, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, and Venezuela.
Product codes and lots: Assembly number 4535 664 98912.

Product code KPS

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)