—#102462

Product

Brilliance 64 Computed Tomography System, Model #78231, Serial Number: 9592. The Brilliance 64 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 difference angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K033326
Affected lot / code info: Model #78231, 510(k) #K03326, Serial Number: 9592.

Why it was recalled

Component defect. Philips Medical decided to conduct a recall field /correction (rework) of the mounting key locking threaded insert of the Detector Module system (DMS) bolt on one (1) Brilliance 64 CT X-ray unit. The firm initiated this action following Philip's receipt of the customer's complaint reporting that the retaining inserts were pulling out of the rotor during the removal of the UDMS

Root cause (FDA determination)

Other

Action the firm took

Philips sent a Field Change Order (FCO) 72800519 on June 13, 2011 to the affected customer. A Field Service Engineer visited the customer site and installed a hardware upgrade to the affected Brilliance 64 device system (Serial Number: 9592). The correction action was completed on August 9, 2011. For questions regarding this recall call 1-440-483-7000.

Recalling firm

Firm: Philips Medical Systems (Cleveland) Inc
Address: 595 Miner Road, Cleveland, Ohio 44143-2131

Distribution

Distribution pattern: Nationwide Distribution including PA

Timeline

Recall initiated: 2011-06-02
Posted by FDA: 2011-09-27
Terminated: 2013-03-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #102462. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.