Philips Medical Systems (Cleveland) Inc Respiratory Gating System, Catalog #NPTA540, Model #4535 674 26701, which includes: Pulmonary digital assembly kit and Pulmonary toolkit oncology Pro available on the following GEMINI PET/CT systems: GEMINI GXL 16 slice configuration, Model Number: 4535 679 75691. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Respiratory Gating System, Catalog #NPTA540, Model #4535 674 26701, which includes: Pulmonary digital assembly kit and Pulmonary toolkit oncology Pro available on the following GEMINI PET/CT systems: GEMINI GXL 16 slice configuration, Model Number: 4535 679 75691.
Brand
Philips Medical Systems (Cleveland) Inc
Lot Codes / Batch Numbers
The affected Serial Numbers are: 4004, 4039, 4045, 4068, 4080, 4104, 4112, 4115, 4117, 4118, 4121, 4127, 4132, 4139, 4146, 4152, 4156, 4158, and 4175.
Products Sold
The affected Serial Numbers are: 4004, 4039, 4045, 4068, 4080, 4104, 4112, 4115, 4117, 4118, 4121, 4127, 4132, 4139, 4146, 4152, 4156, 4158, and 4175.
Philips Medical Systems (Cleveland) Inc is recalling Respiratory Gating System, Catalog #NPTA540, Model #4535 674 26701, which includes: Pulmonary digi due to A leak between the Tube Interface and the Outlet Tube of the transducer for the Respiratory Gating System component may result in a failure of the de. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
A leak between the Tube Interface and the Outlet Tube of the transducer for the Respiratory Gating System component may result in a failure of the device to produce respiratory correlated images.
Recommended Action
Per FDA guidance
Philips Medical Systems Nuclear Medicine division initiated this recall by sending a 'Customer Advisory Notification to their customer accounts on 11/24/2008. This notification informs the customer of the potential for the device equipped with the Pulmonary Gating Option to develop an air leak which could result in the device being unable to produce the desired respiratory correlated images. The notification provides field test instructions and recommends that the customer test the bellows on each day of use in order to assess that the unit is functioning properly. If the bellows device fails the test the recalling firm recommends that the unit not be used and that the recalling firm be contacted via telephone or E-mail. The firm intends to conduct a field correction of the affected units in which their Field Service Engineers will install upgrade kits on the affected devices tentatively scheduled to begin in September, 2009.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
PR
Page updated: Jan 10, 2026