Allura Xper FD10C; System Code: 722001;
USAllura Xper FD10C; System Code: 722001;
Recalling Firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Motivo del Retiro / Peligro
TranslatedPhilips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
Descripción del Producto e Identificación
TranslatedAllura Xper FD10C; System Code: 722001;
Additional Source Details
| Field | Value |
|---|---|
| City | Best |
| Event id | 98434 |
| Address 1 | Veenpluis 6 |
| Code info | System Code: 722001; UDI: N/A; System Serial Number: 19, 249, 21, 18661014, 77, 82, 195, 216, 337, 37, 258, 283, 15, 256, 305; |
| Postal code | N/A |
| Report date | 20260408 |
| Product type | Devices |
| Product quantity | 15 units (7 US, 8 OUS) |
| Reason for recall | Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260303 |
| Initial firm notification | Letter |
| Center classification date | 20260327 |
Consumer Action Protocol: What You Should Do Immediately
Safety StepsInspect the NDC code, batch number, or control number on your medicine bottle or blister packaging to confirm whether your unit is included.
Do not abruptly stop critical prescribed medication without physician advice. Contact your dispensing pharmacist immediately for a safe alternative.
Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.
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 GuideQ1:What should I do immediately if I own or bought Allura Xper FD10C; System Code: 722001;?
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.
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Resumen
- Empresa ResponsablePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- StatusOngoing
- Nivel de RiesgoClass II
- DistributionDomestic: Nationwide Distribution; International: Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei Darussal, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Equatorial Guinea, Estonia, Ethiopia, Fiji, Finland, France, French Polynesia, FrenchPolynesia, Georgia, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Guatemala, Guinea, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Korea, South, Kosovo, Kuwait, Kyrgyzstan, Lao, Laos, Latvia, Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Fed., Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkiye, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Vietnam, Yemen;
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🚨 SAFETY ALERT: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. - Allura Xper FD10C; System Code: 722001; Check if your household is affected: https://therecallfile.com/es/recalls/allura-xper-fd10c-system-code-722001/FDA-Z-1659-2026
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