Accueil/Tous les Rappels/FDA-Z-2287-2026

FDA DevicesClass II

Philips Azurion 5M20, Model Numbers: 722228 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key

Name: Philips Azurion 5M20, Model Numbers: 722228 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the...
Brand: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
SKU: FDA-Z-2287-2026
Availability: Discontinued
Rating: 1.0 (1 reviews)

Publié le: 10 juin 2026ID du rappel: Z-2287-2026Catégorie: Dispositifs MédicauxPays: États-Unis

Medical DeviceFDA Devices

Philips Azurion 5M20, Model Numbers: 722228 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key

Recalling Firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

🌐

Traduire l’alerteTranslate notice text, hazard warnings, and descriptions into any supported language.

Motif du rappel / Danger

During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.

Description du produit & Identification

Philips Azurion 5M20, Model Numbers: 722228 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key

Produits concernés

Philips Azurion 5M20, Model Numbers: 722228 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key

Additional Source Details

Field	Value
City	Best
Event id	98977
Address 1	Veenpluis 6
Code info	UDI (01)00884838099234(21)67, (01)00884838099234(21)49, (01)00884838099234(21)10, (01)00884838099234(21)36, (01)00884838099234(21)64, (01)00884838099234(21)110, (01)00884838099234(21)328, (01)00884838099234(21)149, (01)00884838099234(21)213, (01)00884838099234(21)45, (01)00884838099234(21)159, (01)00884838099234(21)18, (01)00884838099234(21)231, (01)00884838099234(21)61, (01)00884838099234(21)204, (01)00884838099234(21)273, (01)00884838099234(21)76, (01)00884838099234(21)150, (01)00884838099234(21)132, (01)00884838099234(21)189, (01)00884838099234(21)17, (01)00884838099234(21)47, (01)00884838099234(21)38, (01)00884838099234(21)87, (01)00884838099234(21)128, (01)00884838099234(21)32, (01)00884838099234(21)23, (01)00884838099234(21)25, (01)00884838099234(21)62, (01)00884838099234(21)181, (01)00884838099234(21)177, (01)00884838099234(21)48, (01)00884838099234(21)153, (01)00884838099234(21)79, (01)00884838099234(21)80, (01)00884838099234(21)157, (01)00884838099234(21)24, (01)00884838099234... [TRUNCATED]
Postal code	N/A
Report date	20260610
Product type	Devices
Product quantity	51 units
Reason for recall	During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.
Recall initiation date	20231207
Initial firm notification	Letter
Center classification date	20260601

Consumer Action Protocol: What You Should Do Immediately

Safety Steps

1Verify Product Identifiers

Inspect the NDC code, batch number, or control number on your medicine bottle or blister packaging to confirm whether your unit is included.

2Isolate & Discontinue Use

Do not abruptly stop critical prescribed medication without physician advice. Contact your dispensing pharmacist immediately for a safe alternative.

3Claim Free Statutory Remedy

Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.

4Report Adverse Incidents

If you suffered an injury, illness, or property damage from this product, file an official incident report with regulatory authorities (FDA Devices).

Your Legal Rights as a Consumer

Recalls are legally binding corrective safety actions overseen by statutory government bodies. Recalling entities are legally prohibited from charging consumers for official safety remedies. If a retailer or dealership refuses your recall remedy, notify the issuing regulatory agency immediately.

Frequently Asked Questions About This Recall

FAQ Guide

Q1:What should I do immediately if I own or bought Philips Azurion 5M20, Model Numbers: 722228 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the...?

Check the lot number and NDC on your prescription label. For essential medications, consult your doctor or dispensing pharmacist immediately before abruptly stopping your dose.

Q2:Can I get a full refund or free repair for this recall?

Yes. Recalling manufacturers and retail merchants are required under consumer protection regulations to offer a statutory remedy—typically a full refund, certified repair kit, or replacement unit.

Q3:Do I need my original sales receipt to claim a remedy or refund?

In most recall cases, no receipt is required. Because safety recalls are matters of public health and statutory compliance, retailers and manufacturers routinely issue refunds, store credit, or replacement kits upon presentation of the affected product or lot code.

Q4:Where can I verify official information for this safety alert?

This safety alert is aggregated directly from official regulatory agency records (FDA Devices). You can click the 'Official Agency Alert' link on this page to view the primary government notice and contact the manufacturer directly.

Vérifiez les autres produits de votre foyer

Outils gratuits

Safety recalls are issued daily across foods, medications, vehicles, and electronics. Use our instant tools to check your home for active safety warnings:

Lecteur Code-barres Vérificateur NIV Vérificateur Garde-manger

Aperçu

Entreprise responsablePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
StatusOngoing
Niveau de risqueClass II
DistributionUS Nationwide distribution.

Recall Hazard Severity

High Alert (Class I)

Alerte officielle de l’agence

📢 Partager l’alerte

Alert family and friends to keep them safe. Copy this quick alert message:

🚨 SAFETY ALERT: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. - Philips Azurion 5M20, Model Numbers: 722228 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key

Check if your household is affected:
https://therecallfile.com/fr/recalls/philips-azurion-5m20-model-numbers-722228-with-software-release-r2-2-0/FDA-Z-2287-2026

WhatsApp Facebook

Rejoindre la liste d’alerte

Recevez des alertes e-mail instantanées dès qu’un rappel critique est publié.

Support The Recall File

Help keep official recall alerts free, accessible, and fast for everyone.

Spread the WordPhilips Azurion 5M20, Model Numbers: 722228 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key

Philips Azurion 5M20, Model Numbers: 722228 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key

Philips Azurion 5M20, Model Numbers: 722228 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key

Motif du rappel / Danger

Description du produit & Identification

Produits concernés

Additional Source Details

Consumer Action Protocol: What You Should Do Immediately

Your Legal Rights as a Consumer

Frequently Asked Questions About This Recall

Q1:What should I do immediately if I own or bought Philips Azurion 5M20, Model Numbers: 722228 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the...?

Q2:Can I get a full refund or free repair for this recall?

Q3:Do I need my original sales receipt to claim a remedy or refund?

Q4:Where can I verify official information for this safety alert?

Vérifiez les autres produits de votre foyer

Aperçu

📢 Partager l’alerte

Rejoindre la liste d’alerte

Support The Recall File

Install The Recall File App

Notification

Philips Azurion 5M20, Model Numbers: 722228 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key

Philips Azurion 5M20, Model Numbers: 722228 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key

Motif du rappel / Danger

Description du produit & Identification

Produits concernés

Additional Source Details

Consumer Action Protocol: What You Should Do Immediately

Your Legal Rights as a Consumer

Frequently Asked Questions About This Recall

Q1:What should I do immediately if I own or bought Philips Azurion 5M20, Model Numbers: 722228 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the...?

Q2:Can I get a full refund or free repair for this recall?

Q3:Do I need my original sales receipt to claim a remedy or refund?

Q4:Where can I verify official information for this safety alert?

Vérifiez les autres produits de votre foyer

Aperçu

📢 Partager l’alerte

Rejoindre la liste d’alerte

Support The Recall File

Rappels associés

Field Safety Notices: 31 August to 4 September 2026

Field Safety Notices: 31 August to 4 September 2026

Nutra-life Magnesium and Sleep Products and Musashi Pre Workout Chewables

Nutra-life Magnesium and Sleep Products and Musashi Pre Workout Chewables

Aidacare Aspire Active Air 8 Pressure Care Air Mattress

Aidacare Aspire Active Air 8 Pressure Care Air Mattress

Install The Recall File App

Notification