Philips CT Systems Patient Support Table May Descend Unexpectedly
Philips CT systems' patient support table may unexpectedly descend to the lowest position due to ball screw misalignment after component replacement. No injuries have been reported. Affected healthcare facilities should contact Philips for guidance.
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: FDA Class II recall involving medical imaging equipment where the patient support table may unexpectedly descend due to component misalignment. No injuries have been reported, meeting the criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Philips North America LLC is recalling three models of Philips CT systems: the Brilliance 16 Power (Model 728240), Brilliance CT 16 Slice (Model 728246), and Brilliance CT 6 Slice (Model 728256). The patient support table (couch) on these systems may descend unexpectedly to the lowermost position following a component replacement procedure.
The cause is a misalignment of the ball screw component that occurs after replacement. This condition may cause the patient support table to move without operator input, potentially endangering patients during imaging procedures.
A total of 73 units have been distributed worldwide, including throughout the United States and more than 50 additional countries. No injuries have been reported in connection with this issue as of the recall notice.
Hospitals and imaging centers using any of the affected CT system models should immediately discontinue use of the patient support table if they suspect misalignment. Contact Philips North America LLC for guidance on inspection, repair, or replacement of the ball screw component.
The recalled product
- Product
- Philips CT systems labeled as the following: 1. Brilliance 16 Power, Model Number: 728240. 2. Brilliance CT 16 Slice, Model Number: 728246. 3. Brilliance CT 6 Slice, Model Number: 728256.
- Manufacturer
- Philips North America Llc
- Hazard
- mechanical-failure
- patient-injury
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)
- 1. Model Number: 728240
- UDI-DI: N/A
- Serial Number: 6022. 2. Model Number: 728246
- Serial Numbers: 5029
- 5698
- 5834
- 6272
- 6313
- 5307
- 5305
- 50129
- 5286
- 50017
- 5388
- 5424
- 5422
- 5515
- 5497
- 5584
- 5668
Distribution
Distributed nationwide across the United States.
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