Philips CT systems recalled for unexpected patient support table descent
Philips CT systems (Model 728324) may have patient support tables that descend unexpectedly due to ball screw misalignment after replacement, posing a fall risk.
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 without any reported injuries or illnesses. The hazard presents a genuine risk of patient falls or injury from unexpected descent of a patient support table, qualifying it as a risk-of-harm medical device scenario where injury has not yet been reported.
Plain-English summary
Philips North America LLC is recalling 24 units of Ingenuity Core128 / Elite China CT systems (Model 728324) distributed worldwide. The affected units are located throughout the United States and in 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, Russian Federation, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, United Arab Emirates, and Vietnam.
The patient support table (couch) may descend unexpectedly to the lowermost position due to a ball screw component misalignment after replacement. This poses a risk of falls or injury to patients positioned on the support table during imaging procedures.
Healthcare facilities with affected equipment should contact Philips North America LLC or the FDA for information about this recall and recommended corrective actions.
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
- unexpected-descent
- mechanical-failure
- fall-risk
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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