Spectral CT; Product Code (REF): 728333;
Pending LLM rewrite. Source: FDA_DEVICE Z-1317-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
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
- Spectral CT; Product Code (REF): 728333;
- 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): 728333
- UDI-DI: 00884838101111
- Serial Numbers: 10055
- 10075
- 10086
- 10096
- 10106
- 10116
- 10126
- 10136
- 10146
- 10156
- 10166
- 10176
- 10186
- 10196
- 10206
- 10217
- 10227
- 10237
Distribution
Distributed nationwide across the United States.
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