Z-0013-2007

Nuclear medicine systems: Gemini 16, Model 4535 679 28961. Gemini GXL, Models # 4535 679 71891, #4535 679...

Name: Z-0013-2007 Nuclear medicine systems: Gemini 16, Model 4535 679 28961. Gemini GXL, Models # 4535 679 71891, #4535 679...
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2006-11-06
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2006-11-06 / Terminated

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of Nuclear medicine systems: Gemini 16, Model 4535 679 28961. Gemini GXL, Models # 4535 679 71891, #4535 679 75681, #4535 679 75691. Precedence, Model #2169... on 2006-11-06. The reason FDA records is "A potential anomaly was identified on the CT subsytem, which could result in the radiation dose being different than the calculated dose reported to the operator". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0013-2007
Status: Terminated
Initiated: 2006-11-06
Posted: 2007-09-26
Terminated: 2010-10-05
Recalling firm: Philips North America LLC
Product: Nuclear medicine systems: Gemini 16, Model 4535 679 28961. Gemini GXL, Models # 4535 679 71891, #4535 679 75681, #4535 679 75691. Precedence, Model #2169 -3000A, #2169-3001A, #2169-3002A, and 2169-3003A. PET/CT Computed tomography systems.
Product code: KPS System, Tomography, Computed, Emission
Reason for recall: A potential anomaly was identified on the CT subsytem, which could result in the radiation dose being different than the calculated dose reported to the operator.
FDA root cause: Other
Action: The customers were sent Public Safety Notification November 3, 2006, indicating there was a problem with the software. However, since their unit was recently upgraded the problem did not impact their unit.
Quantity in commerce: 70
Distribution: Worldwide, including USA, Australia, Canada, China, England, Finland, France, Germany, Ireland, Israel, Italy, Japan, Jordan, Korea, Netherlands, Poland, Puerto Rico, Spain, and Taiwan.
Product codes and lots: Serial #s: 4034-4100, 4102, 4103, 1041

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)