—#137285

Product

Brilliance CT Big Bore Oncology. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K033357
Affected lot / code info: System Code #, 728243, Serial #, 7039

Why it was recalled

The firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being commanded to do so.

Root cause (FDA determination)

Employee error

Action the firm took

On 3-18-2015 the firm sent Urgent Field Safety Notices to their customers.

Recalling firm

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

Distribution

Distribution pattern: Distributed in China.

Timeline

Recall initiated: 2015-03-16
Posted by FDA: 2015-05-22
Terminated: 2017-02-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #137285. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.