Philips Brilliance CT System Recalled for Finger Squeeze Hazard
Philips is recalling 364 Brilliance CT systems due to a gap in the tilt stand covers that can squeeze fingers during gantry movement.
The agency’s classification
FDA (Devices): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (crush injury) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 364 units of the Brilliance CT System 6/10/16/16P/40 configuration. The recall is due to a gap that can appear between the upper and lower tilt stand covers. This gap creates a risk that fingers may be squeezed if a person places them in the region while the gantry is tilting from an angle to zero tilt angle.
The affected units were distributed worldwide, including in the United States (AZ, CO, GA, IA, IL, IN, KS, KY, MD, MI, MN, MS, NC, NY, OH, OK, TX, VT, and WI) and in countries such as Singapore, New Zealand, India, Australia, Korea, Japan, China, Taiwan, Turkey, France, South Africa, Spain, Italy, Austria, Belgium, Switzerland, Israel, Netherlands, England, and Brazil. The specific model codes involved are 728256, 728251, 728246, 728240, and 728235.
Healthcare facilities and users should contact Philips Medical Systems for instructions on how to address the defect. The source text does not report any specific injuries or illnesses associated with this recall.
The recalled product
- 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.
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Hazard
- Affected units
- 364
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- 728256
- 728251
- 728246
- 728240
- and 728235.
Distribution
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