Philips CT Systems Patient Support Table May Descend Unexpectedly
Philips is recalling certain CT systems because the patient support table may descend unexpectedly to the lowest position due to a component misalignment during replacement.
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 an FDA Class II recall involving medical device equipment where unexpected patient support table descent presents a risk of patient injury or harm. Although no illnesses or injuries are explicitly reported in the source, the hazard (unexpected descent of a patient support structure during medical imaging) is significant and directly threatens patient safety.
Plain-English summary
Philips North America LLC is recalling Ingenuity Core128/Elite China CT systems, Model Number 728324. The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
Twenty-four units have been distributed worldwide, including throughout the United States and countries including Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Mauritius, Mexico, Netherlands, Norway, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, United Arab Emirates, and Vietnam.
If you own or operate one of these CT systems, contact Philips North America LLC for instructions on how to address this issue. The affected units can be identified by their Model Number 728324 and specific serial numbers listed in the recall documentation.
The recalled product
- Product
- Philips CT systems labeled as the following: 1. Ingenuity Core128 / Elite China, Model Number: 728324.
- Manufacturer
- Philips North America Llc
- Hazard
- fall-risk
- unexpected-descent
- component-misalignment
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: 728324
- UDI-DI: 00884838059863
- Serial Numbers: 336821
- 337127
- 336823
- 336824
- 336828
- 336817
- 336952
- 336826
- 336847
- 336857
- 336876
- 336894
- 336948
- 336936
- 336947
- 337012
- 337074
- 337090
Distribution
Distributed nationwide across the United States.
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