Boston Scientific Model 3120 ZOOM LATITUDE Programmer/Recorder/Monitor — Class II medical device recall Z-0673-2024
Ongoing recall by Boston Scientific Corporation, reported 2024-01-17, distributed nationwide. The software application on the Programmer/Recorder/Monitor (PRM) for Implantable Pulse Generators will displa
| Recall number | Z-0673-2024 |
|---|---|
| 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 | 2023-11-30 |
| Classified | 2024-01-05 |
| Reported by FDA | 2024-01-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, AW, BD, BE, BG, BH, BM, BO, BR, BS, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DO, EC, EG, ES, FI, FR, GB, GR, GT, HR, HU, ID, IE, IL, IN, IQ, IR, IS, IT, JM, JO, JP, KE, KR, KW, KY, LB, LK, LT, LU, LV, MA, MT, MX, MY, NI, NL, NO, NZ, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, RS, SA, SE, SG, SK, SV, TH, TN, TR, TT, TW, UA, UY, VE, VN, ZA |
| Quantity | 14,328 zoom |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00802526434723, 00802526435430, 00802526437458, 00802526441974, 00802526442827, 00802526444807, 00802526444814, 00802526445262, 00802526454301, 00802526454950, 00802526456961, 00802526467288, 00802526467295, 00802526467653, 00802526468582, 00802526469343, 00802526469350, 00802526469374, 00802526473449, 00802526474057, 00802526474170, 00802526474859, 00802526475450, 00802526475467, 00802526475474 and 137 more |
| Model numbers | 2892, 3120 |
Product
Boston Scientific Model 3120 ZOOM LATITUDE Programmer/Recorder/Monitor (PRM) installed with Model 2892 Programmer Application Software used for the following pacemaker products: ALTRUA 20, ALTRUA 40, ALTRUA 60, INSIGNIA I Entra, INSIGNIA I Plus, INSIGNIA I Ultra, NEXUS I Entra, and NEXUS I Plus. ALTRUA 20, ALTRUA 40, ALTRUA 60, INSIGNIA I Entra, INSIGNIA I Plus, INSIGNIA I Ultra, NEXUS I Entra, and NEXUS I Plus.
Reason for recall
The software application on the Programmer/Recorder/Monitor (PRM) for Implantable Pulse Generators will display certain diagnostic dates incorrectly, with a year in the 1990s.
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-0673-2024. 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.