Philips Brilliance iCT Computed Tomography X-ray System Recall for Torque Wrench Malfunction
Philips is recalling two Brilliance iCT Computed Tomography X-ray systems because a supplier torque wrench malfunction may have resulted in incorrect fastener torque.
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 is classified as FDA Class II and involves a risk-of-harm product (medical device) 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 two Brilliance iCT Computed Tomography X-ray systems. The recall involves Model# 728306 with serial numbers 85019 and 85023. These units were distributed internationally to China and Norway.
The recall was initiated because a calibrated torque wrench malfunctioned at the supplier, which may have led to incorrect torque on the x-ray tube mounting fasteners. The FDA has classified this as a Class II recall.
Healthcare facilities that possess these specific serial numbers should contact the recalling firm for instructions on how to proceed. The source text does not specify a consumer action for the general public, as these are medical devices intended for professional use.
The recalled product
- Product
- Brilliance iCT Computed Tomography X-ray system
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Hazard
- Affected units
- 2
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 (2)
- Model# 728306
- Serial #'s: 85019 & 85023.
Distribution
Distribution scope not specified by the agency.
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