Philips CT Systems Patient Support Table May Descend Unexpectedly
Philips is recalling 3 Ingenuity CT Family Brazil scanner units due to a potential defect where the patient support table may descend unexpectedly to the lowest position after ball screw replacement. No injuries have been reported.
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 of medical equipment with mechanical defect affecting patient support function, but no reported injuries or illnesses. Meets rubric criterion for High severity: risk-of-harm product where injury has not yet been reported.
Plain-English summary
Philips North America LLC is recalling 3 units of the Ingenuity CT Family Brazil CT scanner system (Model 728325) because the patient support table may descend unexpectedly.
The patient support table (couch) may descend unexpectedly to its lowermost position due to misalignment of the ball screw component after it is replaced. This occurs as a result of a defect in the component.
These units were distributed worldwide, including throughout the United States and to healthcare facilities in numerous countries. No injuries have been reported in connection with this issue.
The recalled product
- Product
- Philips CT systems labeled as the following: 1. Ingenuity CT Family Brazil, Model Number: 728325.
- Manufacturer
- Philips North America Llc
- Category
- Medical Device — CT Scanner
- Hazard
- unexpected-descent
- 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 (5)
- 1. Model Number: 728325
- UDI-DI: N/A
- Serial Numbers: 338014
- 338028
- 338019.
Distribution
Distributed nationwide across the United States.
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