Recall Z-1178-2017 ยท LWS Implantable Cardioverter Defibrillator (Non-Crt)
Boston Scientific Corporation
Boston Scientific, EMBLEM S-ICD Programmer Model 3200 Programmer.
| Date | Jan 12, 2017 |
| Status | Terminated |
| Reason | There is a potential for radio frequency (RF) interference to alter wireless communication from a programmer, which in rare instances may cause an S-ICD to perform an unintended command. This behavior can only occur during an active, in-clinic interrogation/programming session with the Model 3200 S-ICD programmer. There is no risk of this behavior occurring when the LATITUDE Patient Management System communicates with an S-ICD in an ambulatory setting. |
| Root cause | Software design |
| Action | Boston Scientific sent an "Important Medical Device Information" letter dated on January 12, 2017. The letter was addressed to "Dear Doctor". The letter included information on the Description and Clinical Implications, Rate of Occurrence, Recommendations, Affected Programmer & Additional Information. For additional questions regarding this communication or to report clinical events, contact your Boston Scientific representative or Technical Services at 1 800-227-3422. |
| Quantity | 4,500 |
| Distribution | Worldwide Distribution - USA ( nationwide) including PR and to the states of : AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY., and to the countries of |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.