ATTACHMENT J_CERTIFICATION OF RECALL OR SAFETY ISSUES_NX EQ TEE SCANNING SYSTEMS.docx
DOCX document 32 KB Posted
- Solicitation number
- 36C10X27R0011
About this file
This is a Certification of Recall or Safety Issues form for NX EQ Transesophageal Echocardiography (TEE) Scanning Systems submitted to the Department of Veterans Affairs Strategic Acquisition Center Frederick under Solicitation Number 36C10X27R0011.
The form serves as a certification document requiring vendors to disclose any recalls, safety issues, or related incidents associated with the NX EQ TEE Scanning Systems being offered. Vendors must attest to whether their equipment has experienced any recalls, safety alerts, field actions, or corrective actions issued by the Food and Drug Administration (FDA) or other regulatory bodies. The certification requires detailed information about any safety incidents, including dates, descriptions of issues, corrective actions taken, and documentation supporting such disclosures. This certification is a mandatory submission requirement for all proposals and ensures that the VA is fully informed of any product safety concerns prior to award and delivery of equipment. The form establishes accountability and compliance with federal procurement standards for medical device acquisitions within the Veterans Affairs system.
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Other files
| File | Type | Posted |
|---|---|---|
| ATTACHMENT E_REPORTING TOOL_NX EQ TEE SCANNING SYSTEMS.xlsx | XLSX spreadsheet | |
| S02 36C10X27R0011 Combined Synopsis Solicitation.docx | DOCX document | |
| ATTACHMENT B_CONTRACT ADMINISTRATION_NX EQ TEE SCANNING SYSTEMS.docx | DOCX document | |
| ATTACHMENT F_PAST PERFORMANCE REFERENCE_NX EQ TEE SCANNING SYSTEMS.docx | DOCX document | |
| ATTACHMENT G_PAST PERFORMANCE QUESTIONNAIRE_NX EQ TEE SCANNING SYSTEMS.docx | DOCX document | |
| ATTACHMENT C_CONTRACT CLAUSES_NX EQ TEE SCANNING SYSTEMS.docx | DOCX document | |
| ATTACHMENT D_SOLICITATION PROVISIONS_NX EQ TEE SCANNING SYSTEMS.docx | DOCX document | |
| ATTACHMENT H_RFQ QUESTIONS_NX EQ TEE SCANNING SYSTEMS.xlsx | XLSX spreadsheet | |
| ATTACHMENT A_PRICE COST SCHEDULE_NX EQ TEE SCANNING SYSTEMS.xlsx | XLSX spreadsheet |
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Text version
Attachment J Certification of Recall or Safety Issues Instructions to Offerors:
1. Complete all fields in the certification form.
2. Ensure that the form is signed by an authorized representative of the company.
3. Submit the completed form along with your quote.
Certification of No Outstanding Recalls or Safety Issues Solicitation Number: 36C10X27R0011 Requirement for: NX EQ TEE Scanning Systems
Company Unique Entity Identifier (UEI): __________________________________________
Certification:
By signing below, I, the undersigned, certify on behalf of the company identified by the UEI above, the medical equipment quoted in response to the above-referenced solicitation:
1. Does not have any outstanding recalls.
2. Does not have any known safety issues.
3. Complies with all relevant regulations and standards for medical equipment.
4. Has been thoroughly checked for compliance with safety and performance standards.
I understand that any false or misleading information provided in this certification may result in disqualification from the solicitation process and other penalties as permitted by law.
Authorized Representative:
Name: __________________________________________ Title: __________________________________________ Signature: __________________________________________ Date: __________________________________________
File details come from the government source that posted it. Updated .