Philips Brilliance iCT SP CT Systems Patient Support Table Descent
Philips is recalling Brilliance iCT SP CT systems due to a ball screw misalignment that may cause the patient support table to descend unexpectedly to its lowest position.
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: This is an FDA Class II recall of medical imaging equipment where the hazard—unexpected descent of a patient support table—presents a risk of patient injury (fall, crush, or trauma). The source text does not report any actual illnesses or injuries, but the mechanical failure creates a credible risk of harm in a clinical setting.
Plain-English summary
Philips North America LLC is recalling Brilliance iCT SP CT systems (Model Number 728311) distributed worldwide, including throughout the US. The patient support table (couch) may descend unexpectedly to the lowermost position due to component misalignment after a replacement.
Affected units are identified by serial numbers: 200016, 200024, 200211, 200041, 200030, 200060, 200048, 200069, 200098, 200097, 200112, 200136, 200200, 200209. A total of 14 units have been distributed to facilities in the US and internationally.
Patients and healthcare facilities using affected Philips Brilliance iCT SP systems should discontinue use of the patient support table if misalignment is suspected. Contact Philips North America LLC immediately for guidance on inspection, repair, or replacement of the affected component. Do not operate the system until the issue has been resolved by a qualified technician.
The recalled product
- Product
- Philips CT systems labeled as the following: 1. Brilliance iCT SP, Model Number: 728311.
- Manufacturer
- Philips North America Llc
- Affected units
- 14
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 (16)
- 1. Model Number: 728311
- UDI-DI: N/A
- Serial Number: 200016
- 200024
- 200211
- 200041
- 200030
- 200060
- 200048
- 200069
- 200098
- 200097
- 200112
- 200136
- 200200
- 200209.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 10 recalled by Philips North America Llc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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