Reported Oct 11, 2023 · Ongoing
Incisive CT, software version 5.0
Philips Healthcare
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 · 222 Jacobs St · Cambridge, MA · 02141-2289
Is this the product you have?
- Incisive CT, software version 5.0
- Lot codes and dates
- software version 5.0
- Amount recalled
- 140 systems
Where it was sold
- Nationwide
Why it was recalled
Philips has identified three software issues with compliance concerns to Subchapter J: Issue 1: Coronary Computed Tomography Angiography (CTA) scan may not be triggered at the optimal time. Issue 2: Use of aborted surview for scan planning will result in deviation from intended scan area. Issue 3: Actual clinical scan with bariatric (Noah) couch will deviate from the intended scan area if surview scan length is greater than 1832mm.
This product could cause temporary or reversible health problems — stop using it.
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