Reported Jan 17, 2024 · Ongoing
Incisive CT, model 728143 & 728144 running Software Version 5.0.0.
Philips Healthcare (Suzhou) Co., Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips Healthcare (Suzhou) Co., Ltd. · Suzhou Industrial Park · Suzhou · N/A
Is this the product you have?
- Incisive CT, model 728143 & 728144 running Software Version 5.0.0.
- Lot codes and dates
- UDI-DI00884838085015 (Model 728143)
- UDI-DI00884838105508 (Model 728144)
- Amount recalled
- 828
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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