Philips Medical Systems (Cleveland) Inc No packaging. The device is a computed tomography scanner. Intended to provide corss sectional images of the human body and visualization of the internal organs of the body. 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
No packaging. The device is a computed tomography scanner. Intended to provide corss sectional images of the human body and visualization of the internal organs of the body.
Brand
Philips Medical Systems (Cleveland) Inc
Lot Codes / Batch Numbers
Model 728243 Software version 2.2.1 and 2.2.2
Products Sold
Model 728243 Software version 2.2.1 and 2.2.2
Philips Medical Systems (Cleveland) Inc is recalling No packaging. The device is a computed tomography scanner. Intended to provide corss sectional due to When the Extended Display Firled ov View reconstruction is used, the CT numbers and anatomy in teh extended region are not accurate.. 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
When the Extended Display Firled ov View reconstruction is used, the CT numbers and anatomy in teh extended region are not accurate.
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
AR, CA, FL, KY, LA, MD, MA, MI, MN, MO, NJ, NY, OH, PA, RI, SC, TX, VT, VA
Page updated: Jan 11, 2026