The PRM is intended to be used as part of the ZOOM LATITUDE… — Class II medical device recall Z-1671-2022
Ongoing recall by Boston Scientific Corporation, reported 2022-09-07. There is potential for unanticipated software anomalies to occur when using the Model 2868 Application loaded
| Recall number | Z-1671-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Saint Paul, MN, United States |
| Recall initiated | 2022-07-07 |
| Classified | 2022-09-01 |
| Reported by FDA | 2022-09-07 |
| Quantity | 17,172 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00802526434723, 00802526435430, 00802526437458, 00802526441974, 00802526442827, 00802526444807, 00802526444814, 00802526445262, 00802526454301, 00802526454950, 00802526456961, 00802526467288, 00802526467295, 00802526467301, 00802526467653, 00802526468582, 00802526469343, 00802526469350, 00802526469374, 00802526473449, 00802526474170, 00802526474859, 00802526475450, 00802526475467, 00802526475474 and 96 more |
| Serial numbers | 00802526435430, 00802526437458, 00802526441974, 00802526442827, 00802526444807, 00802526444814, 00802526445262, 00802526454301, 00802526454950, 00802526456961, 00802526467288, 00802526467295, 00802526467301, 00802526467653, 00802526468582, 00802526469343, 00802526469350, 00802526469374, 00802526473449, 00802526474170, 00802526474859, 00802526475450, 00802526475467, 00802526475474, 00802526475757 and 475 more |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1671-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.