# FDA recall Z-0375-2026

> **PHILIPS MEDICAL SYSTEMS** · Class II · device recall initiated 2025-09-25.

## Product

Model: Incisive CT;  Product Code (REF): (1) 728143, (2) 728144;  Software Versions: 5.1.0.X & 5.1.1.X;

## Reason for recall

Issue 1: The potential for unintentional continued gantry/couch movement when a specific button series is used requiring use of manual stop.  Issue 2. When performing a helical/Axial scan with ORI (Dose Right index)/ DOM (Dose Modulation), the  WED (Water Equivalent Diameter) value might set itself to zero, and this may lead to an insufficient  dose setting after the surview. If operator misses the insufficient dose and the WED value in User  Interface and continues with the subsequent helical/Axial scans, then the obtained images will be noisy due to low dose setting.  Issue 3: Due to a software failure, the ECG wave file is not saved. As a result, the cardiac offline image reconstruction fails due to the missing ECG wave file, and the user might rescan the patient.  Issue 4: This issue is software fault in which the patient orientation will be changed to NULL under specific random scenarios resulting in radiation being delivered from the wrong orientation (surview scan) or in the wro

## Distribution

Domestic: AL, AR, CA, CT, FL, GA, IL, IN, KY, MD, MI, OH, PA, PR, TN, TX, UT, VA;  International: Argentina, Australia, Austria, Brazil, Czeck Republic, Denmark, Ecuador, Finland, France, Germany, Guyana, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Kenya, Latvia, Lebanon, Libya, Netherlands, Nicaragua, Norway, Panama, Philippines, Poland, Portugal, Reunion, Romania, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, U.A.E., Yemen;

## Key facts

- **Recall number:** Z-0375-2026
- **Recalling firm:** PHILIPS MEDICAL SYSTEMS
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-09-25
- **Report date:** 2025-11-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Cambridge, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0375-2026

## Citation

> AI Analytics. FDA recall Z-0375-2026. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0375-2026. Source: US FDA. Licensed CC0.

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