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 during procedures.
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 risk-of-harm product (medical device) where the hazard is the misinterpretation of images, but the source text does not report any specific injuries or illnesses, fitting the 'High' criteria for risk-of-harm products without reported injury.
Plain-English summary
Philips Electronics North America Corporation is recalling the INTEGRIS HM3000 (Model 72239) and various Allura systems, including Allura Xper, Allura Clarity, Allura CV, and Allura Centron. The recall involves 13,297 units distributed worldwide, including the United States and numerous international locations.
The recall is issued because the use of these systems regarding live and still images can lead to still images being interpreted as live images. This error could affect the interpretation of diagnostic and interventional procedures.
Healthcare facilities and users should contact Philips for further instructions on how to address this issue. The source text does not specify a particular corrective action or timeline for the recall.
The recalled product
- Product
- INTEGRIS HM3000; Model Number: 72239 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
- 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 · misinterpretation
See all →- HighNatus SD LTM 64 PLUS EEG recorders may shift traces one second
FDA (Devices) · 2026-06-17
- HighRoche 9180 Electrolyte Analyzer Recalled for Incorrect Calcium Display Arrows
FDA (Devices) · 2021-02-17
- HighMindray BeneVision Distributed Monitoring System Recalled for ECG Display Anomalies
FDA (Devices) · 2018-10-24
- HighSiemens Gentamicin Reagent Cartridge Recall Due to Low-End Inaccuracy
FDA (Devices) · 2018-06-20
- HighInvivo DynaCAD Software Recalled for Incorrect Pharmacokinetic Map Display
FDA (Devices) · 2018-04-11