Philips Allura Xper FD20 Recall for Image Interpretation Error
Philips is recalling Allura Xper FD20 systems because still images may be misinterpreted as live images, potentially affecting diagnostic accuracy.
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 is classified as FDA Class II, and the hazard involves a risk of harm (misinterpretation of medical images) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Philips Electronics North America Corporation is recalling 13,297 Allura Xper FD20 systems (Model Numbers 722028, 722012, and 722006) due to a software issue. The recall covers units distributed worldwide, including the United States and numerous international markets.
The recall is issued because the use of Allura Xper, Allura Clarity, Allura CV, Allura Centron, and UNIQ systems regarding live and still images can lead to still images being interpreted as live images. This error may impact the accuracy of diagnostic and interventional procedures, such as angiography, stent placements, and other vascular or neurovascular applications.
Healthcare facilities and users of these systems should contact Philips for instructions on how to resolve the issue. The recall affects all serial numbers of the specified models.
The recalled product
- Product
- Allura Xper FD20; Model Numbers: 722028 722012 722006 Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral, thoracic and abdominal angiography, as well as PTCAs, stent placements
- Manufacturer
- Philips Electronics North America Corporation
- Category
- Medical Device — Imaging System
- 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