Recall Z-0673-2024 ยท LWS Implantable Cardioverter Defibrillator (Non-Crt)
Boston Scientific Corporation
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,
| Date | Jan 5, 2024 (initiated Nov 30, 2023) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | The recalling firm issued letters flagged "Important Medical Device Information" dated 30 November 2023 to Dear Physician or Healthcare Professional (HCP) via Federal Express or courier with signed receipt in the U.S. on 11/30/2023. The letter provides a description of unanticipated behavior and clinical impact and provides a recommendation to keep the letter with all Model 3120 programmers at their center or distribute the letter to all HCPs who perform pacemaker checks using a Model 3120 ZOOM programmer. When using the Model 2892 software application on the programmer, if a date includes a |
| Quantity | 14,328 ZOOM programmers |
| Distribution | Distribution was nationwide, including Guam, Puerto Rico, and the U.S. Virgin Islands. There was also government/military distribution. Foreign distribution was made to Andorra, Argentina, Aruba, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Benin, Bermuda, Bolivia, Bosnia an |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.