Philips CT Exam Tables May Unexpectedly Descend During Patient Use
Philips Brilliance iCT CT systems may have faulty patient support tables that descend unexpectedly due to component misalignment, creating a risk of patient injury.
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: This is a Class II medical device recall involving a risk-of-harm hazard (patient drop or fall during examination). Per the rubric, risk-of-harm products where injury has not yet been reported score 3 (High). No deaths, hospitalizations, or reported illnesses are mentioned in the source.
Plain-English summary
Philips North America LLC is recalling 210 units of its Brilliance iCT CT systems worldwide, including those distributed in the United States. The patient support table (couch) on affected units may descend unexpectedly to the lowest position due to misalignment of a component known as the ball screw after it has been replaced.
An unexpected descent of the patient support table during patient examination could create a risk of injury or falls. No injuries or illnesses have been reported in association with this issue.
Facilities using affected CT systems should contact Philips North America LLC for instructions regarding repairs or replacement options. Specific serial numbers of affected units have been provided by the manufacturer for identification purposes.
The recalled product
- Product
- Philips CT systems labeled as the following: 1. Brilliance iCT, Model Number: 728306.
- Manufacturer
- Philips North America Llc
- Hazard
- patient-fall
- mechanical-failure
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: 728306
- UDI-DI: 00884838059474
- Serial Number: 100068
- 100188
- 100241
- 100288
- 100332
- 100365
- 100461
- 85007
- 85016
- 100657
- 100682
- 100686
- 100779
- 100832
- 100783
- 100775
- 100788
- 100807
Distribution
Distributed nationwide across the United States.
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