FDAFDA · Alimentos y medicamentos·N.º oficial Z-2572-2018
VNS Therapy Programming System, Rx Only, Model 3000, v1.0.2.2
Publicado el 8 de agosto de 2018 · Inicio del retiro: 24 de enero de 2018
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
Unintended warning message displayed on generators programmed with a Model 3000 v.1.0.2.2 programmer.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- LivaNova USA Inc
- Distribuidor
- Distributed domestically to AZ, CA, GA, IA, IL, IN, MO, MT, NC, NY, PA, SD, TN, TX, WA, WI.
- Lote
- Part Number 10-0011-0500; Serial Number (UDI Number): FMT77F2 (01054250257503991117091821FMT77F29910 0011 0500), FKR57F2 (01054250257503991117091821FKR57F29910 0011 0500), FCR77F2 (01054250257503991117091821FCR77F29910 0011 0500), CJR77F2 (01054250257503991117091821CJR77F29910 0011 0500), BNT77F2 (01054250257503991117091821BNT77F29910 0011 0500), BNS77F2 (01054250257503991117091821BNS77F29910 0011 0500), 7XR77F2 (010542502575039911170918217XR77F29910 0011 0500), 7XP57F2 (010542502575039911170918217XP57F29910 0011 0500), 79R77F2 (0105425025750399111709182179R77F29910 0011 0500), 90S77F2 (0105425025750399111709182190S77F29910 0011 0500), 97Q57F2 (0105425025750399111709182197Q57F29910 0011 0500), 6NT77F2 (010542502575039911170918216NT77F29910 0011 0500), 9GP57F2 (010542502575039911170918219GP57F29910 0011 0500), 6KQ57F2 (010542502575039911170918216KQ57F29910 0011 0500), B7Q57F2 (01054250257503991117091821B7Q57F29910 0011 0500), 57P57F2 (0105425025750399111709182157P57F29910 0011 0500), 55T77F2 (0105425025750399111709182155T77F29910 0011 0500), J6R57F2 (01054250257503991117091821J6R57F29910 0011 0500), HWR77F2 (01054250257503991117091821HWR77F29910 0011 0500), 1G7G1F2 (010542502575039911170918211G7G1F29910 0011 0500), 1JR57F2 (010542502575039911170918211JR57F29910 0011 0500), 9XP57F2 (010542502575039911170919219XP57F29910 0011 0500), 4LR77F2 (010542502575039911170919214LR77F29910 0011 0500), 4GT77F2 (010542502575039911170919214GT77F29910 0011 0500), 4GR57F2 (010542502575039911170919214GR57F29910 0011 0500), 2DT77F2 (010542502575039911170919212DT77F29910 0011 0500), G2S77F2 (01054250257503991117092021G2S77F29910 0011 0500), FVQ77F2 (01054250257503991117092021FVQ77F29910 0011 0500), G5T77F2 (01054250257503991117092021G5T77F29910 0011 0500), FDQ57F2 (01054250257503991117092021FDQ57F29910 0011 0500), F5R57F2 (01054250257503991117092021F5R57F29910 0011 0500), F2R57F2 (01054250257503991117092021F2R57F29910 0011 0500), F1Q57F2 (01054250257503991117092021F1Q57F29910 0011 0500), GHS77F2 (01054250257503991117092021GHS77F29910 0011 0500), DVR77F2 (01054250257503991117092021DVR77F29910 0011 0500), DNP57F2 (01054250257503991117092021DNP57F29910 0011 0500), DMYB7F2 (01054250257503991117092021DMYB7F29910 0011 0500), DJS77F2 (01054250257503991117092021DJS77F29910 0011 0500), D1R57F2 (01054250257503991117092021D1R57F29910 0011 0500), CVQ57F2 (01054250257503991117092021CVQ57F29910 0011 0500), H4R57F2 (01054250257503991117092021H4R57F29910 0011 0500), 85S77F2 (0105425025750399111709202185S77F29910 0011 0500), 89T77F2 (0105425025750399111709202189T77F29910 0011 0500), 8LYB7F2 (010542502575039911170920218LYB7F29910 0011 0500), 97YB7F2 (0105425025750399111709202197YB7F29910 0011 0500), 6MQ57F2 (010542502575039911170920216MQ57F29910 0011 0500), 6CQ57F2 (010542502575039911170920216CQ57F29910 0011 0500), 5HS77F2 (010542502575039911170920215HS77F29910 0011 0500), JLQ57F2 (01054250257503991117092021JLQ57F29910 0011 0500), JGS77F2 (01054250257503991117092021JGS77F29910 0011 0500), 11R57F2 (0105425025750399111709202111R57F29910 0011 0500), 1TQ57F2 (010542502575039911170920211TQ57F29910 0011 0500), 1YR77F2 (010542502575039911170920211YR77F29910 0011 0500), 2DR77F2 (010542502575039911170921212DR77F29910 0011 0500), FXP57F2 (01054250257503991117092121FXP57F29910 0011 0500), FTR77F2 (01054250257503991117092121FTR77F29910 0011 0500), FPQ57F2 (01054250257503991117092121FPQ57F29910 0011 0500), FNQ57F2 (01054250257503991117092121FNQ57F29910 0011 0500), FLYB7F2 (01054250257503991117092121FLYB7F29910 0011 0500), FFP57F2 (01054250257503991117092121FFP57F29910 0011 0500), GGT77F2 (01054250257503991117092121GGT77F29910 0011 0500), GSQ57F2 (01054250257503991117092121GSQ57F29910 0011 0500), CMS77F2 (01054250257503991117092121CMS77F29910 0011 0500), H1R77F2 (01054250257503991117092121H1R77F29910 0011 0500), H3R57F2 (01054250257503991117092121H3R57F29910 0011 0500), 7LS77F2 (010542502575039911170921217LS77F29910 0011 0500), 9KR57F2 (010542502575039911170921219KR57F29910 0011
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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