—#129644

Product

No packaging. The device is a computed tomography scanner. Intended to provide corss sectional images of the human body and visualization of the internal organs of the body.

FDA product code: JAX — Pneumotachometer
Device class: Class 2
Medical specialty: Anesthesiology
510(k) numbers: K033357
Affected lot / code info: Model 728243 Software version 2.2.1 and 2.2.2

Why it was recalled

When the Extended Display Firled ov View reconstruction is used, the CT numbers and anatomy in teh extended region are not accurate.

Root cause (FDA determination)

Labeling design

Action the firm took

Philips sent a Product Safety Notification letter dated December 21, 2006 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to distribute the Product Safety Notification to all affected users and keep a copy of the notification with the Instructions for Use until further notice. Customers with questions were instructed to contact Customer Care Center at 1-800-722-9377, option 5 - Diagnostic Imaging, option 1 - CT. For questions regarding this recall call 440-483-7600.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution - US including MO, TX, MD, AR, VA, KY, RI, NJ, MA, NY, LA, PA, VT, SC, CA, OH, FL, MN, MI and Internationally to Netherlands, Canada, Finland, Austria, France, Malaysia, Denmark, Norway, UK, Australia, Belgium, New Zealand.

Timeline

Recall initiated: 2007-01-09
Posted by FDA: 2014-09-22
Terminated: 2015-11-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #129644. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.