Vertical Brake Hubs component of the Philips MX8000 Series Dual v. Exp. Computed Tomography System, Serial Numbers: 8008

FDA device recall Z-2914-2011 · posted 2011-08-01 · Terminated

Recall details

Recalling firm

Philips Medical Systems (Cleveland) Inc

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

Action taken

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).

Root cause

Device Design

Status

Terminated

Product code

KPS

Quantity affected

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 count

Date initiated

2011-06-03

Date posted

2011-08-01

Date terminated

2013-08-07

Location

Cleveland, OH

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