Z-0132-2009

Respiratory Gating System which includes: Pulmonary Digital Assembly Kit and Pulmonary Toolkit Oncology Pro...

Name: Z-0132-2009 Respiratory Gating System which includes: Pulmonary Digital Assembly Kit and Pulmonary Toolkit Oncology Pro...
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2008-09-22
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2008-09-22 / Terminated / root cause: manufacturing process

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of Respiratory Gating System which includes: Pulmonary Digital Assembly Kit and Pulmonary Toolkit Oncology Pro, Model #455011203131 and Model #455011203191 on 2008-09-22. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0132-2009
Status: Terminated
Initiated: 2008-09-22
Posted: 2008-10-28
Terminated: 2012-03-01
Recalling firm: Philips North America LLC
Product: Respiratory Gating System which includes: Pulmonary Digital Assembly Kit and Pulmonary Toolkit Oncology Pro, Model #455011203131 and Model #455011203191.
Product code: KPS System, Tomography, Computed, Emission
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 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, Sweden, and Thailand.
Product codes and lots: All units of Model numbers 455011203131 and 455011203191.

Product code KPS

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)