Respiratory Gating System which includes: Pulmonary Digital Assembly Kit and Pulmonary Toolkit Oncology Pro, Model #455011203131 and Model #455011203191.
FDA Recall Z-0132-2009 · Posted 2008-10-28
Advertisement
Recalling FirmPhilips Medical Systems (Cleveland) Inc
Recall StatusTerminated
Product CodeKPS
Date Initiated2008-09-22
Date Terminated2012-03-01
Product Quantity507 units
Reason for Recall
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.
Firm 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.
Root Cause
Process design
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement