[pending] Brilliance iCT; Product Code (REF): 728306;
Pending LLM rewrite. Source: FDA_DEVICE Z-1315-2026.
What this means for you
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: Pending LLM scoring against the rubric.
Plain-English summary
As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification. If multiple fasteners are not torqued to specification, the rotor or rotor parts may become unsecured or displaced. While there has been no reported or observed event of expelled parts during gantry rotation, unsecured rotor parts may potentially be expelled.
The recalled product
- Product
- Brilliance iCT; Product Code (REF): 728306;
- Manufacturer
- Philips North America Llc
- Category
- Medical Device — Devices
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)
- Product Code (REF): 728306
- UDI-DI: 00884838059474
- Serial Numbers: 87064
- 87120
- 87121
- 87122
- 87125
- 87126
- 87127
- 87128
- 87129
- 87130
- 87135
- 87143
- 87148
- 87152
- 87153
- 87157
- 87160
- 87162
Distribution
Distributed nationwide across the United States.
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