Boston Scientific is recalling 14,328 Model 3120 ZOOM LATITUDE Programmer/Recorder/Monitor (PRM) units equipped with Model 2892 software. These devices are used by healthcare providers to program and monitor pacemakers, including ALTRUA, INSIGNIA, and NEXUS models. The software contains a defect where specific diagnostic dates are displayed incorrectly with a year in the 1990s, which could lead to confusion regarding patient history or device performance.
Incorrect diagnostic dates can cause healthcare providers to misinterpret patient data or clinical history. This software error may lead to clinical decisions being based on inaccurate timelines of device performance or cardiac events.
Manufacturer correction via notification letter.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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