Philips Healthcare (Suzhou) Co., Ltd. recalls Philips Incisive CT
Potential for incomplete scan due to unstable connection inside of floating sensor.
Read the official notice →- Date
- 2026-01-14
- Country
- United States
- Brand
- Philips Healthcare
- Product
- Philips Incisive CT
- Classification
- Class II
- Units
- U.S. and U.S. territories
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Philips Healthcare recalls
- 2026-09-02
US
Philips Healthcare (Suzhou) Co., Ltd. recalls Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Code 728144.
Potential of failing to trigger clinical scan during Bolus Tracking.
FDA · DevicePhilips Healthcare (Suzhou) Co., Ltd.U.S. Nationwide and U.S. Territories distribution.Official notice →- 2024-01-17
US
Philips Healthcare (Suzhou) Co., Ltd. recalls Incisive CT, model 728143 & 728144 running Software Version 5.0.0.
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…
FDA · DevicePhilips Healthcare (Suzhou) Co., Ltd.Worldwide - US Nationwide distribution including in the states of AL, AR, AZ,…Official notice →- 2023-10-11
US
Philips Healthcare recalls Incisive CT, software version 5.0
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…
- 2022-04-13
US
Philips Healthcare recalls Philips StentBoost Live R2.0 application, when used with the Philips Azurion with software release R2.x
Due to an incorrect configuration setting in the EPX database of StentBoost Live, acquisition does not stop automatically as it should. When the user selects the StentBoost Live protocol on the Philips Azurion system,…
- 2022-03-30
US
Philips Healthcare recalls Azurion systems with software release R2.0.x
In the Azurion system, the user can add a new study to a patient by selecting the option "Add Study". The Add Study dialogue box is then displayed where the Patient Type is selected to perform the study. Due to a…
- 2021-12-01
US
Philips Healthcare recalls CombiDiagnost R90 is multi-functional general R/F systems.
The Aleva monitor requires certain labels to be applied, some of which are required by FDA Electronic Product Radiation Control performance standards. This includes the Radiation Warning Label [21CFR 1020.30 (j)] and…
Other drugs & medical recalls in the United States
- 2026-01-14
US
Meridian Bioscience Inc recalls Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300
The affected lots show a decline in performance over time, which may lead to false-negative results.
FDA · DeviceMeridian Bioscience IncUS Nationwide distribution and the OUS country of Italy.Official notice →US
Applied Medical Resources Corp recalls Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm REF: CTB23
There is the potential for extended length of the blade obturator after assembly into the cannula and seal housing.
FDA · DeviceApplied Medical Resources CorpUS: MI, CA, ME, OUS: France Great Britain, GermanyOfficial notice →US
Roche Diagnostics Operations, Inc. recalls The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with streptavidin-coated microparticles and…
Issues identified: 1) Results vary by Instrument Platform; 2) Calibrator Lot-to-Lot Variability. Issues may lead to delayed or incorrect diagnosis, as well as delay of treatment or incorrect treatment.
FDA · DeviceRoche Diagnostics Operations, Inc.US Nationwide distribution in the states of AZ, CA, FL, GA, IL, IN, ME, MI,…Official notice →US
AVID Medical, Inc. recalls Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOF1000-17.
Devices are not suitable for organ transplant.
FDA · DeviceAVID Medical, Inc.US Nationwide distribution in the states of FL, GA and Puerto Rico.Official notice →US
Siemens Medical Solutions USA, Inc recalls LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471
A potential issue associated with LUMINOS Lotus Max and Luminos dRF Max systems with software version VF11 with bucky wall stand for mobile detectors and without ceiling stand .When switching quickly between organ…
US
Vision RT Ltd recalls The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s position and movement.
Vision RT is informing customers of an omission identified in the Instructions for Use for AlignRT InBore systems. Information identifying the lasers and their characteristics was omitted from the Instructions for Use…