BVI Leos Laser and Endoscopy System. Model Number: OME6000U.
USBVI Leos Laser and Endoscopy System. Model Number: OME6000U.
Recalling Firm: Beaver-Visitec International, Inc.
Motif du rappel / Danger
TranslatedManufacturing deviation in which the ferrites specified for the USB cable assembly linking the Nurse Monitor touchscreen to the System Controller were not installed as intended. The omission of the ferrites on the USB communication cable results in non-conformance to the design specifications, which require two ferrites (one at each end of the cable).
Description du produit & Identification
TranslatedBVI Leos Laser and Endoscopy System. Model Number: OME6000U.
Additional Source Details
| Field | Value |
|---|---|
| City | Waltham |
| State | MA |
| Event id | 98076 |
| Address 1 | 500 Totten Pond Rd |
| Address 2 | N/A |
| Code info | Model Number: OME6000U. UDI: (01)00886158037576(11)250513(21). Serial Numbers: 77UBV500003, 77UBV500004, 77UBV500005, 77UBV500006, 77UBV500010. |
| Postal code | 02451-1916 |
| Report date | 20260107 |
| Product type | Devices |
| Product quantity | 5 units |
| Reason for recall | Manufacturing deviation in which the ferrites specified for the USB cable assembly linking the Nurse Monitor touchscreen to the System Controller were not installed as intended. The omission of the ferrites on the USB communication cable results in non-conformance to the design specifications, which require two ferrites (one at each end of the cable). |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251205 |
| Initial firm notification | |
| Center classification date | 20251231 |
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 BVI Leos Laser and Endoscopy System. Model Number: OME6000U.?
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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Aperçu
- Entreprise responsableBeaver-Visitec International, Inc.
- StatusOngoing
- Niveau de risqueClass II
- DistributionUS Nationwide distribution in the states of FL, MI, OK, TX, WI.
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🚨 SAFETY ALERT: Beaver-Visitec International, Inc. - BVI Leos Laser and Endoscopy System. Model Number: OME6000U. Check if your household is affected: https://therecallfile.com/fr/recalls/bvi-leos-laser-and-endoscopy-system-model-number-ome6000u/FDA-Z-1008-2026
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