Recall Z-2678-2014 ยท JAX Pneumotachometer
Philips Medical Systems (Cleveland) Inc
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.
| Date | Sep 22, 2014 (initiated Jan 9, 2007) |
| Status | Terminated |
| Reason | When the Extended Display Firled ov View reconstruction is used, the CT numbers and anatomy in teh extended region are not accurate. |
| Root cause | Labeling design |
| Action | 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. |
| Quantity | 61 |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033357 | ACQSIM-MULTISLICE-CT, MODEL 453567042271 Philips Medical Systems (Cleveland), Inc., Jan 9, 2004 |