MAXXUS, System, Tomography, Computed, Emission
USMAXXUS, System, Tomography, Computed, Emission
Recalling Firm: GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Grund für den Rückruf / Gefahr
TranslatedGE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as Impacted Systems and listed in the Affected Product Details section of this letter) could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury. There have been no reports of detector falls or injuries as a result of this potential issue. The Impacted Systems affected by this notice are those that have not been manufactured for several years. GE HealthCare has previously communicated End of Guaranteed Service for these Impacted Systems.
Produktbeschreibung & Identifikation
TranslatedMAXXUS, System, Tomography, Computed, Emission
Betroffene Produkte
TranslatedMAXXUS, System, Tomography, Computed, Emission
Additional Source Details
| Field | Value |
|---|---|
| City | Tirat Carmel |
| Event id | 98133 |
| Address 1 | 4, Hayozma St |
| Code info | UDI/DI Not applicable: All serial numbers in distribution |
| Postal code | N/A |
| Report date | 20260121 |
| Product type | Devices |
| Product quantity | 38 units |
| Reason for recall | GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as Impacted Systems and listed in the Affected Product Details section of this letter) could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury. There have been no reports of detector falls or injuries as a result of this potential issue. The Impacted Systems affected by this notice are those that have not been manufactured for several years. GE HealthCare has previously communicated End of Guaranteed Service for these Impacted Systems. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251210 |
| Initial firm notification | Telephone |
| Center classification date | 20260109 |
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 MAXXUS, System, Tomography, Computed, Emission?
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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Übersicht
- Rückrufendes UnternehmenGE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
- StatusOngoing
- RisikostufeClass II
- DistributionUS, Brazil, Egypt, Canada, Mexico, Turkey, Italy, Sweden, Switzerland, France, Spain Chile, Germany, Iran, Greece
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🚨 SAFETY ALERT: GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING - MAXXUS, System, Tomography, Computed, Emission Check if your household is affected: https://therecallfile.com/de/recalls/maxxus-system-tomography-computed-emission/FDA-Z-1047-2026
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