Respiratory Gating System, Catalog Number: NPTA540, Model #4535 674 26701, for the following affected CT/PET scanning de

FDA device recall Z-0287-2010 · posted 2009-11-17 · Terminated

Recall details

Recalling firm

Philips Medical Systems (Cleveland) Inc

Reason for recall

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.

Action taken

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.

Root cause

Process design

Status

Terminated

Product code

JAK

Quantity affected

51 units

Distribution

Worldwide distribution: USA, Puerto Rico, Canada, Belgium, China, Denmark, Egypt, France, Germany, Hong Kong, India, Japan, Netherlands, Pakistan, Philippines, Poland, Saudi Arabia, Singapore, South K

Date initiated

2008-11-24

Date posted

2009-11-17

Date terminated

2010-09-24

Location

Cleveland, OH

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