ATTACHMENT H - CERTIFICATION OF RECALL OR SAFETY ISSUES.docx

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Attached to
NX EQ Scanning System Ultrasonic Endoscopic
Solicitation number
36C10G26R0005
Issued by

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This document is an Attachment H Certification of Recall or Safety Issues form for the NX EQ Scanning System Ultrasonic Endoscopic solicitation (Solicitation Number: 36C10G26R0005) issued by the Veterans Health Administration (VHA). The certification requires vendors to affirm that their medical equipment has no outstanding recalls, no known safety issues, complies with relevant regulations, and has been thoroughly checked for safety and performance standards.

The associated federal contract opportunity seeks a national single Requirements contract for Scanning System Ultrasonic Endoscopic machines used in VA medical centers. The device combines a camera and ultrasound technology to create diagnostic images of the digestive tract, used for cancer diagnosis, staging, biopsies, cyst drainage, and targeted medication delivery. The contract period includes a 12-month base period with four 12-month option periods, and requires contractors to demonstrate the ability to meet all solicitation requirements for providing these medical scanning systems to VA clinicians.

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Attachment H Certification of Recall or Safety Issues Instructions to Quoters:

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: 36C10G26R0005 Requirement for: NX EQ Scanning System Ultrasonic Endoscopic

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: __________________________________________

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