—#73718

Product

Respiratory Gating System which includes: Pulmonary Digital Assembly Kit and Pulmonary Toolkit Oncology Pro, Model #455011203131 and Model #455011203191.

FDA product code: KPS — System, Tomography, Computed, Emission
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K012009, K033326, K033357
Affected lot / code info: All units of Model numbers 455011203131 and 455011203191.

Why it was recalled

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 (FDA determination)

Process design

Action the firm took

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.

Recalling firm

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

Distribution

Distribution pattern: 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, Sweden, and Thailand.

Timeline

Recall initiated: 2008-09-22
Posted by FDA: 2008-10-28
Terminated: 2012-03-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #73718. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.