Philips CT Systems Recalled for Improper Vertical Motor Assembly
Philips is recalling Brilliance and Ingenuity CT systems because improper assembly of the vertical motor/brake system may lead to uncommanded vertical motion.
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 (uncommanded motion of a medical device) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling various Brilliance and Ingenuity Computed Tomography (CT) X-ray systems. The recall involves 500 units distributed nationwide in the United States and to numerous foreign countries.
The recall is due to improper assembly of the vertical motor/brake system, which may lead to uncommanded vertical motion of the device. This defect could pose a risk of injury to patients or operators if the table moves unexpectedly during use.
Healthcare facilities should contact Philips Medical Systems to arrange for inspection and repair of the affected units. The affected models include Brilliance CT 16 Air, Brilliance CT 64, Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology, Brilliance iCT, Brilliance iCT SP, Ingenuity CT, Ingenuity Core, Ingenuity Core128, and Ingenuity Flex.
The recalled product
- Product
- Various Brilliance and Ingenuity Computed Tomography X-ray systems; one unit per package Product Usage: Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. This device may include…
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Affected units
- 500
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 (20)
- Brilliance CT 16 Air: Model Number 728246: Serial Numbers: 3117
- 6680
- 6692
- 6693
- 6697
- 6698
- 6700
- 6703
- 6706
- 6707
- 6708
- 6709
- 6711
- 6712
- 6713
- 6715
- 6716
- 6718
- 6719
- 6720
Distribution
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