Recall Z-1670-2022 ยท LWS Implantable Cardioverter Defibrillator (Non-Crt)
Boston Scientific Corporation
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.
| Date | Jul 7, 2022 |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | Boston Scientific notified their consignees by letter on 07/07/2022. The Important Programmer Information stated the following: "Programmer Software Information July 2022 - Continued use of older Model 2868 software on Model 3120 ZOOM programmers to support transvenous CRT-Ds and ICDs until supply constraints on newer programmers are resolved. Summary- " Global supply chain challenges have constrained availability of the newer programmers. " Until the supply chain constraints are resolved locally, you may continue using older 3120 ZOOM programmers. " The 2868 software on the 3120 ZOOM prog |
| Quantity | 17,172 units in total |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.