Recall Z-0132-2009 ยท KPS System, Tomography, Computed, Emission
Philips Medical Systems (Cleveland) Inc
Respiratory Gating System which includes: Pulmonary Digital Assembly Kit and Pulmonary Toolkit Oncology Pro, Model #455011203131 and Model #455011203191.
| Date | Oct 28, 2008 (initiated Sep 22, 2008) |
| Status | Terminated |
| Reason | Images not correlated: A leak between the Tube Interface and the Outlet Tube of the transducer may result in a failure to produce respiratory correlated images. |
| Root cause | Process design |
| Action | On 9/8/2008 Philips Medical Systems sent recall notification letters to their customers requesting they inventory their stock. They sent instructions to verify that the product is working properly. They are also sending Field Service Engineers to each customer to conduct field test. |
| Quantity | 507 units |
| Distribution | Worldwide distribution: USA, Australia, Austria, Bahrain, Belgium, Canada, China, Czech Republic, Denmark, England, Finland, France, Germany, Israel, Italy, Japan, Jordan, Korea, Lithuania, Malaysia, Netherlands, Norway, New Zealand, Puerto Rico, South Africa, Saudi Arabia, Spain, Switzerland, Swede |
| FDA record | Open on fda.gov |