FDA Medical Device Recalls (openFDA)
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 number
- Z-0286-2010
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- 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.
- Status
- Terminated
- Initiated
- 2008-11-24
- Posted
- 2009-11-17
- Terminated
- 2010-09-24
- Reason
- 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.
- Root cause
- Process design
- Action
- 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.
- Quantity
- 20 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 Korea, Spain, and Sweden.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K033357","K051170"]
- PMA numbers
- not on file
- Product code
- JAK
- Firm FEI
- 1525965
- Firm city
- Cleveland
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28