Incisive CT, model 728143 & 728144 running Software Version 5.0.0.
Class I - Dangerous 🏥 Medical Devices
Recalled: December 23, 2022 Philips Healthcare (Suzhou) Co. Infusion Pumps
Nationwide
What Should You Do?
- Check if you have this product: UDI-DI: 00884838085015 (Model 728143) UDI-DI: 00884838105508 (Model 728144)
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Philips Healthcare (Suzhou) Co., Ltd.
- Reason for Recall:
- Multiple software issues which have the potential to lead to misdiagnosis due to image artifacts or incorrect image orientation labels, or the need for a CT rescan. These include: 1. Artifacts may occur on perfusion images, 2. Orientation label reversed in 2D images, 3. Auto voice does not work during the cardiac scan, 4. Auto voice and operators voice are too quiet, patient cant hear, 5. Not all of the images are reconstructed in some cases, 6. No image displayed on the console monitor after enabling CCT Single Scan, 7. Ring artifact appears in 32x0.625 collimation of bone scan when soft tissue view is selected, 8. A design defect where the error couch motion signal of couch firmware causes couch to identify current position as target position in next protocol, and 9. calcium scoring study split into separate series after loading to ISP.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Incisive CT, model 728143 & 728144 running Software Version 5.0.0.
Product Codes/Lot Numbers:
UDI-DI: 00884838085015 (Model 728143) UDI-DI: 00884838105508 (Model 728144)
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0640-2024
Related Recalls
Philips CT systems are advanced continuous-rotation computed tomography systems suitable for a wide range of computed tomographic (CT) applications - Product Usage: intended for use in the head and whole body.
Philips Healthcare (Suzhou) Co.
Class I - Dangerous
Philips has internally detected an issue with the actuators used in the Incisive CT couch, which could result in the couch failure to self-lock, and unexpectedly moving slowly downward to its limit position.