Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model Number (REF): 781341. 3. Model Number (REF): 781396. 4. Model Number (REF): 782115. 510(k) Numbers: K163116, K173079, K183063, K193215, K213583, K223458, K251397, K251808
USPhilips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model Number (REF): 781341. 3. Model Number (REF): 781396. 4. Model Number (REF): 782115. 510(k) Numbers: K163116, K173079, K183063, K193215, K213583, K223458, K251397, K251808
Recalling Firm: Philips North America
Motif du rappel / Danger
TranslatedThe potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Description du produit & Identification
TranslatedPhilips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model Number (REF): 781341. 3. Model Number (REF): 781396. 4. Model Number (REF): 782115. 510(k) Numbers: K163116, K173079, K183063, K193215, K213583, K223458, K251397, K251808
Produits concernés
TranslatedPhilips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model Number (REF): 781341. 3. Model Number (REF): 781396. 4. Model Number (REF): 782115. 510(k) Numbers: K163116, K173079, K183063, K193215, K213583, K223458, K251397, K251808
Additional Source Details
| Field | Value |
|---|---|
| City | Cambridge |
| State | MA |
| Event id | 98779 |
| Address 1 | 222 Jacobs St |
| Code info | 1. Model Number (REF): 781315. UDI: (01)00884838099715(21)61067, (01)00884838099715(21)61058, (01)00884838099715(21)61056. Serial Numbers: 61067 61058, 61056. 2. Model Number (REF): 781341. UDI: (01)00884838055322(21)70229, (01)00884838055322(21)84667, (01)00884838055322(21)70311, (01)00884838055322(21)70668, (01)00884838055322(21)70845, (01)00884838055322(21)70851, (01)00884838055322(21)87151, (01)00884838055322(21)87112, (01)00884838055322(21)84322, (01)00884838055322(21)84323, (01)00884838055322(21)84228, (01)00884838055322(21)84789, (01)00884838055322(21)84261, (01)00884838055322(21)84500, (01)00884838055322(21)84556, (01)00884838055322(21)87187, (01)00884838055322(21)84840, (01)00884838055322(21)70685, (01)00884838055322(21)84661, (01)00884838055322(21)70787, (01)00884838055322(21)70063, (01)00884838055322(21)70621, (01)00884838055322(21)70743, (01)00884838055322(21)70911, (01)00884838055322(21)84049, (01)00884838055322(21)84088, (01)00884838055322(21)84147, (01)00884838055322(21... [TRUNCATED] |
| Postal code | 02141-2296 |
| Report date | 20260506 |
| Product type | Devices |
| Product quantity | 54 units |
| Reason for recall | The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260414 |
| Initial firm notification | Letter |
| Center classification date | 20260427 |
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 Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model Number (REF): 781341. 3. Mod...?
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
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Aperçu
- Entreprise responsablePhilips North America
- StatusOngoing
- Niveau de risqueClass II
- DistributionWorldwide - US Nationwide and the countries of Argentina, Australia, Bangladesh, Belgium, Brazil, Canada, Chile, Cuba, Cyprus, Denmark, Ecuador, Egypt, France, Germany, Greece, Hong Kong, India, Indonesia, Iran, Iraq, Israel, Italy, Japan, Kenya, Lebanon, Lithuania, Malta, Mexico, Myanmar, Netherlands, Pakistan, Palestine, Peru, Poland, Portugal, Russian Fed., Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Kingdom.
📢 Partager l’alerte
Alert family and friends to keep them safe. Copy this quick alert message:
🚨 SAFETY ALERT: Philips North America - Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model Number (REF): 781341. 3. Model Number (REF): 781396. 4. Model Number (REF): 782115. 510(k) Numbers: K163116, K173079, K183063, K193215, K213583, K223458, K251397, K251808 Check if your household is affected: https://therecallfile.com/fr/recalls/philips-ingenia-1-5t-with-mr-elastography-mre-1-model-number-ref-78131/FDA-Z-1956-2026
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