---
title: "Azure S DR MRI SureScan, Product number W3DR01 — FDA record Z-1924-2025 | Is It on Recall"
description: "Identified devices may experience sudden battery power failure without alarm, power supply power-on-resets, and interruption of therapy. Potential patient harms"
url: https://isitonrecall.com/recall/fda-device-z-1924-2025-azure-s-dr-mri-surescan-product-number-w3dr01/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# Azure S DR MRI SureScan, Product number W3DR01 — FDA record Z-1924-2025

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Apr 29, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: Azure S DR MRI SureScan, Product number W3DR01
- **Reason**: Identified devices may experience sudden battery power failure without alarm, power supply power-on-resets, and interruption of therapy. Potential patient harms include insufficient pacing support leading to cardiac arrest, syncope, or hospitalization; or system revision (explant/replacement) leading to infection, hematoma, or temporary impairment.
- **Classification**: Class II
- **Recalling firm**: Medtronic, Inc.
- **Quantity**: 6
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-1924-2025

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1924-2025%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | Serial numbers RNJ108800G, RNJ108808G, RNJ108810G UDI-DI 00763000956004 \*\*\*Updated 10/14/25\*\*\* Scope expanded to include implanted devices, serial numbers: RNJ108803G RNJ108804G RNJ108820G |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

International distribution of the country of UK. No US distribution.

No US distribution state could be established from this record. Check the official notice.

## Dates in the source

- **Report date**: Jun 18, 2025
- **Recall initiation date**: Apr 29, 2025
- **Center classification date**: Jun 6, 2025

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1924-2025%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Medtronic Inc records](https://isitonrecall.com/brand/medtronic-inc/)