Class II Recall

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

Summary

The FDA issued a Class II for Model: Incisive CT; Product Code (REF): (1) 728143, (2) 728144; Software Versi by PHILIPS MEDICAL SYSTEMS. Reason: Issue 1: The potential for unintentional continued gantry/couch movement when a specific button series is used requiring use of manual stop. Issue 2..

Details

Source

Device Recall

External ID

Z-0375-2026

Action Date

2025-11-05

Status

Ongoing

Product Description

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

Lot/Code Info: 1. Product Code (REF): 728143; UDI-DI: 00884838085015; Serial Numbers: 500417, 500404, 500408, 500277, 500037, 500475, 500243, 500028, 500024, 510003, 33022, 500521, 500444, 500305, 500174, 500150, 500029, 500018, 500546, 500472, 510023, 510008, 500532, 500483, 500471, 500446, 500258, 500195, 500568, 33005, 2. Product Code (REF): 728144; UDI-DI: 00884838105508; Serial Numbers: 550375, 550259, 550241, 550195, 550187, 550159, 550116, 550063, 550052, 55400406111940, 550298, 550092, 550188, 5400406113211, 550467, 550328, 550177, 550136, 34318, 550300, 550296, 550248, 550234, 34252, 34224, 34217, 34176, 34157, 34147, 34142, 34108, 550605, 550580, 550129, 550103, 550056, 500509, 34499, 34458, 34405, 34136, 550040, 550447, 550041, 550359, 550350, 34546, 34188, 550686, 550065, 550059, 550025, 500506, 34237, 550474, 550141, 550115, 34401, 552001, 34529, 34408, 34532, 34516, 34280, 34259, 34251, 34223, 34208, 34179, 34174, 34159, 34137, 34082, 34080, 34003;

Quantity Affected: 105 units

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 wrong position (clinical scan) and will generate incorrect and undiagnosable surview/clinical images. Patients may be rescanned for surview and/or clinical images. Issue 5: During scanning, the preview image display is not consistent, the images are not arriving at a fixed rate, skipping images from time to time during scanning. The obtained images might not support making the clinical diagnosis and the user might decide to re-scan the patient. Issue 6: If a user presses the left and middle/right mouse buttons together or afterwards in a short time, both commands are executed and an incorrect auto ROI is created. This ROI coordinates won t be assigned as the object is empty. As a result, the threshold of contrast level will not be reached in the UI and this will prevent the system from automatically triggering the subsequent clinical scan. There is potential safety risk identified for additionally tracker shots and/or rescan of a patient when the clinical scan is not triggered. This issue only affects the manual ROI process.

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;

Type: Voluntary: Firm initiated

Recall Initiated: 2025-09-25

Company

PHILIPS MEDICAL SYSTEMS

Cambridge, MA

Context & Analysis

This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.

This was one of 284 device recalls issued in the same week, part of 403 device-related FDA actions this month.

PHILIPS MEDICAL SYSTEMS has 10 FDA actions in our database, including 8 recalls and 2 clearances.

Frequently Asked Questions

What is a Class II recall?

A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (PHILIPS MEDICAL SYSTEMS) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does PHILIPS MEDICAL SYSTEMS have FDA actions?

PHILIPS MEDICAL SYSTEMS has 10 FDA actions in our database, including 8 recalls and 2 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "Z-0375-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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