# FDA recall Z-1670-2022

> **Boston Scientific Corporation** · Class II · device recall initiated 2022-07-07.

## Product

The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

## Reason for recall

There is potential for unanticipated software anomalies to occur when using the Model 2868 Application loaded on the 3120 ZOOM LATITUTDE programmer when communicating with certain Boston Scientific transvenous defibrillators.

## Distribution

Worldwide Distribution

## Key facts

- **Recall number:** Z-1670-2022
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-07-07
- **Report date:** 2022-09-07

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Saint Paul, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1670-2022

## Citation

> AI Analytics. FDA recall Z-1670-2022. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-1670-2022. Source: US FDA. Licensed CC0.

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