Philips Spectral CT on Rails. Model Number: 728334.
USPhilips Spectral CT on Rails. Model Number: 728334.
Recalling Firm: PHILIPS MEDICAL SYSTEMS
Motivo del Retiro / Peligro
TranslatedPhilips has identified three software issues: 1. During a continuous CT (CCT) scan, there is the potential that the Gantry could remain at the current scan position after pressing Go. 2. Potential where the message of Previous Surview Exists Select Previous Surview? <Yes> or <No> should display but does not appear. 3. After performing Surview and planning the Brain Helical acquisition by setting Brain Area DoseRight Index to increase the dose, there is the potential that the Define Head Area option in the context menu is grayed out.
Descripción del Producto e Identificación
TranslatedPhilips Spectral CT on Rails. Model Number: 728334.
Additional Source Details
| Field | Value |
|---|---|
| City | Cambridge |
| State | MA |
| Event id | 98588 |
| Address 1 | 222 Jacobs St |
| Address 2 | N/A |
| Code info | Model Number: 728334. UDI: (01)00884838103627(21)1005, (01)00884838103627(21)1006, (01)00884838103627(21)1007. Software Version Number: 5.1.X. Serial Numbers: 1005, 1006, 1007. |
| Postal code | 02141-2289 |
| Report date | 20260422 |
| Product type | Devices |
| Product quantity | 3 systems |
| Reason for recall | Philips has identified three software issues: 1. During a continuous CT (CCT) scan, there is the potential that the Gantry could remain at the current scan position after pressing Go. 2. Potential where the message of Previous Surview Exists Select Previous Surview? <Yes> or <No> should display but does not appear. 3. After performing Surview and planning the Brain Helical acquisition by setting Brain Area DoseRight Index to increase the dose, there is the potential that the Define Head Area option in the context menu is grayed out. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260307 |
| Initial firm notification | Letter |
| Center classification date | 20260416 |
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 Spectral CT on Rails. Model Number: 728334.?
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
- StatusOngoing
- Nivel de RiesgoClass II
- DistributionWorldwide - US Nationwide distribution in the states of Minnesota and the countries of France and Netherlands.
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🚨 SAFETY ALERT: PHILIPS MEDICAL SYSTEMS - Philips Spectral CT on Rails. Model Number: 728334. Check if your household is affected: https://therecallfile.com/es/recalls/philips-spectral-ct-on-rails-model-number-728334/FDA-Z-1825-2026
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