Philips CT Scanner May Display Images With Incorrect Orientation
Philips Incisive CT X-ray systems may display medical images in incorrect orientation, potentially leading to misdiagnosis, incorrect treatment, and unnecessary radiation exposure if rescans are needed.
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 of a medical imaging device. While no illnesses or injuries have been reported, the potential for incorrect image orientation could result in serious consequences including misdiagnosis and unnecessary radiation exposure. Per FDA criteria, risk-of-harm products without reported incidents receive a High severity rating.
Plain-English summary
Philips Headquarters Cambridge is recalling Incisive CT whole-body computed tomography (CT) X-ray systems due to a potential issue with image orientation. The systems may display medical images in incorrect orientation, with images potentially appearing flipped or reversed.
Incorrect image orientation can lead physicians to misinterpret medical images, resulting in misdiagnosis and inappropriate treatment of patient conditions. It may also result in patients receiving unnecessary additional radiation exposure if a scan must be repeated.
The recall affects 7 units in the United States (distributed to Arkansas, California, Oklahoma, and Texas) and 76 units outside the United States across multiple countries. Specific serial numbers have been identified by the manufacturer to determine affected equipment.
The recalled product
- Product
- Incisive CT- whole-body computed tomography (CT) X-Ray System Model Number: 728144
- Manufacturer
- PHILIPS HEADQUARTERS CAMBRIDGE
- Hazard
- image-orientation-error
- misdiagnosis-risk
- radiation-exposure
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 (6)
- UDI-Di: (01)00884838105508(21) Serial Numbers: 34053
- 34092
- 34164
- 34168
- 34179
- 34195
Distribution
Distributed in 4 states:
- AR
- CA
- OK
- TX
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