Philips Medical Systems (Cleveland) Inc Brilliance CT System 6/10/16/16P/40 configuration. No packaging, sold as single unit. Computed tomography scanner intended to provide cross sectional images of the human body and visualization of the internal organs. Recall
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Brilliance CT System 6/10/16/16P/40 configuration. No packaging, sold as single unit. Computed tomography scanner intended to provide cross sectional images of the human body and visualization of the internal organs.
Brand
Philips Medical Systems (Cleveland) Inc
Lot Codes / Batch Numbers
728256, 728251, 728246, 728240, and 728235.
Products Sold
728256, 728251, 728246, 728240, and 728235.
Philips Medical Systems (Cleveland) Inc is recalling Brilliance CT System 6/10/16/16P/40 configuration. No packaging, sold as single unit. Computed due to The system has a gap that can appear between the upper and lower tilt stand covers. The fingers may be squeezed if a person was to place them in this . This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The system has a gap that can appear between the upper and lower tilt stand covers. The fingers may be squeezed if a person was to place them in this region while the gantry was tilting from an angle to zero tilt angle.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
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
AZ, CO, GA, IL, IN, IA, KS, KY, MD, MI, MN, MS, NY, NC, OH, OK, TX, VT, WI
Page updated: Jan 11, 2026