Urgent Field Safety Notice | 合法醫療器材資訊網

Summary. • Approximately 47,000 EMBLEM S-ICD1 Subcutaneous Electrodes (Model 3501) have been distributed worldwide since 2017 with an overall survival ... Read More

A Product Advisory is a voluntary letter issued to inform physicians of an anomalous device ... June 2021 EMBLEM Electrode 3501 Removal Physician Letter. Read More

2020年12月24日 — Subject: Important Medical Device Advisory - EMBLEM™ S-ICD Subcutaneous Electrode (Model 3501) with a potential for electrode body fracture ... Read More

2020年12月6日 — Subject: Important Medical Device Advisory – EMBLEM™ S-ICD Subcutaneous Electrode (Model 3501) with a potential for electrode body fracture ... Read More

Based on LATITUDE Date on File, Boston Scientific 2017. **For full warranty terms and ... 3501, EMBLEM S-ICD Electrode. 4711, EMBLEM S-ICD Electrode ... Read More

1. EMBLEM MRI S-ICD User's Manual 359480-001 EN US 2015-11. 2. MRI Technical Guide 359474-001 EN US 2015-11. Compatible Electrodes. 3400, 3401, 3501. Read More

2021年2月10日 — Boston Scientific Recalls EMBLEM S-ICD Subcutaneous Electrode (Model 3501) Due to Risk of Fractures ... The FDA has identified this as a Class I ... Read More

由 SC Remole 著作 · 2021 — On December 2, 2020, a medical advisory letter regarding EMBLEM S-ICD subcutaneous electrode model 3501 (Boston Scientific, Marlborough, ... Read More

2021年1月19日 — Product, EMBLEM S-ICD Subcutaneous Electrode Model 3501. ... Boston Scientific will post the product advisory letter on our website, ... Read More