Philips INTEGRIS and Allura Systems Recalled for Image Interpretation Error
Philips is recalling INTEGRIS and Allura systems because a software issue may cause still images to be mistaken for live images.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device where a software defect could lead to misinterpretation of patient images, posing a risk of harm even though specific injuries are not reported in the source text.
Plain-English summary
Philips Electronics North America Corporation is recalling specific models of INTEGRIS and Allura medical imaging systems. The affected products include the INTEGRIS CV (Model 722030), INTEGRIS 3000 I 5000, INTEGRIS Allura 9 Biplane, and INTEGRIS Allura 12 & 15 systems. These devices are intended for interventional and diagnostic vascular, neurovascular, and cardiovascular procedures.
The recall is due to a software issue affecting the Allura Xper, Allura Clarity, Allura CV, Allura Centron, and UNIQ systems. The defect can cause still images to be interpreted as live images by the user. This error could lead to misinterpretation of patient data during diagnostic or interventional procedures.
A total of 13,297 units are affected by this recall. The distribution is worldwide, including the United States (nationwide, including Puerto Rico) and numerous international countries. All serial numbers are included in the recall. Users of these systems should contact Philips for instructions on how to resolve the issue.
The recalled product
- Product
- INTEGRIS CV; Model Number: 722030 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional pr
- Manufacturer
- Philips Electronics North America Corporation
- Category
- Medical Device — Imaging Systems
- Affected units
- 13,297
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All serial numbers.
Distribution
Part of a larger recall action
This product is one of 29 recalled by Philips Electronics North America Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 29 products in this recall →Related recalls
Same manufacturer · Philips Electronics North America Corporation
See all →- HighPhilips Xper Flex Cardio Physiomonitoring System Recalled for Display Errors
FDA (Devices) · 2018-12-26
- ModeratePhilips IntelliVue MX40 Patient Monitor Speaker Volume Recall
FDA (Devices) · 2018-12-19
- HighPhilips Medical Monitor Ceiling Suspension Recall for Detachment Risk
FDA (Devices) · 2018-10-03
- HighPhilips Allura Xper FD2O Ceiling Monitor Suspension Recall
FDA (Devices) · 2018-10-03
- HighPhilips AlIura Xper F010 F Monitor Ceiling Suspension Recall
FDA (Devices) · 2018-10-03
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02