Spectral CT Devices Pose Collision and Misdiagnosis Software Risks
Philips Spectral CT and Spectral CT Plus devices may fail to update plan positioning during interventional procedures, creating collision risks to operators and patients. A software defect may also assign incorrect patient IDs, potentially causing misdiagnosis.
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 Class II FDA recall involves two serious software defects: plan box update failure during interventional procedures creates collision and injury risk to operator and patient; patient identification error could lead to misdiagnosis. However, the source reports no actual injuries or illnesses, and hazards are characterized as potential rather than confirmed, meeting the criterion for High severity: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Philips North America LLC is recalling 301 units of Spectral CT and Spectral CT Plus devices (Model Numbers 728333, 728340, and 728344, software version 5.0.X). These computed tomography imaging systems are deployed in medical facilities worldwide.
The U.S. Food and Drug Administration has classified this as a Class II recall due to two software defects. First, during interventional procedures, the plan box may fail to update correctly, potentially causing collision with the operator or with a needle placed inside the patient. Second, a patient identification software issue may cause incorrect patient records to be associated with imaging data, which could lead to misdiagnosis.
The affected devices have been distributed throughout the United States and internationally to Australia, Austria, Belgium, China, Czech Republic, Denmark, Ecuador, France, Germany, Hong Kong, Israel, Italy, Japan, Jordan, Macao, Malaysia, Netherlands, New Zealand, Norway, Palestine, Panama, Poland, Portugal, Singapore, South Korea, Spain, Switzerland, Taiwan, Thailand, the United Kingdom, and Vietnam. Hospitals and imaging centers operating these devices should contact Philips North America LLC for information about remediation options.
The recalled product
- Product
- Spectral CT and Spectral CT Plus. Model Numbers: 728333, 728340, 728344.
- Manufacturer
- Philips North America Llc
- Category
- Medical Device — CT Scanner
- Hazard
- collision-risk
- misdiagnosis-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)
- 10261
- 10264
- 10219
- 10265
- 10197
- 10182
- 10175
- 10192
- 10179
- 10196
- 10180
- 10188
- 10190
- 10181
- 10183
- 10178
- 10186
- 10185
- 10199
- 10184
Distribution
Distributed nationwide across the United States.
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