Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0673-2024 — 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.

U.S. FDA — Device Enforcement · United States · 2023-11-30 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0673-2024
Date of alert: 2023-11-30
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Boston Scientific Corporation
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00802526434723

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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