FDA Medical Device Recalls (openFDA)
Philips Medical Systems (Cleveland) Inc: Philips Medical Systems, GEMINI GXL 6, 10, & 16 slice PET/CT Systems, diagnostic imaging systems for fixed or mobile installations that combine Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems, Philips Medical Systems, Cleveland, OH 44143
- Recall number
- Z-0462-2008
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Product
- Philips Medical Systems, GEMINI GXL 6, 10, & 16 slice PET/CT Systems, diagnostic imaging systems for fixed or mobile installations that combine Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems, Philips Medical Systems, Cleveland, OH 44143
- Status
- Terminated
- Initiated
- 2007-09-21
- Posted
- 2008-01-31
- Terminated
- 2012-03-02
- Reason
- Artifacts: Artifacts may appear in some images from head scans on the CT subsystem of the GEMINI PET/CT system. Reading images with these artifacts may lead to misdiagnosis or improper treatment.
- Root cause
- Software design
- Action
- Philips Medical notified domestic customers via Product Safety Notification dated May 30, 2007. The product safety notification includes a Technical Bulletin notifying customers of the issue and how to avoid it. This information will be used until the software correction becomes available. The software correction will be released in October 2008. Once software is available, the firm will begin correcting the field.
- Quantity
- 126
- Distribution
- Worldwide Distribution - USA, Australia, Belgium, Canada, China, Denmark, England, Finland, France, Germany, Hong Kong, Hungary, India, Ireland, Italy, Japan, Jordan, Korea, Netherlands, Poland, Portugal, Saudi Arabia, Slovenia, Spain, Sweden, Taiwan, Turkey, and Venezuela.
- Lot, serial or model codes
- Gemini GXL Product Numbers/Manufacturer Numbers: GXL 16 slice: 4535 679 71891, GXL 10 slice: 4535 679 75681, GXL 6 slice: 4535 679 75691. Catalog Numbers: GXL 16 slice: 882410, GXL 10 slice: 882400, GXL 6 slice: 882390. Serial Numbers: 4034-4159.
- 510(k) numbers
- ["K051170","K052640"]
- PMA numbers
- not on file
- Product code
- KPS
- 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