Recall Z-0816-03 ยท LWS Implantable Cardioverter Defibrillator (Non-Crt)
Biotronik Inc
Belos VR - implantable cardioverter defibrillator. Implantable Cardioverter Defibrillators. The Belos VR is a single-chamber implantable cardioverter defibrillator (ICD) that detects and treats ventricular tachyarrhythmias and provides rate adaptive bradycardia pacing support. The ICDs are designed to collect diagnostic data to aid the physician''s assessment of a patient''s condition and the p
| Date | May 14, 2003 (initiated Mar 21, 2003) |
| Status | Terminated |
| Reason | Potential extended charge time anomalies |
| Root cause | Other |
| Action | The firm issued a letter dated 3/21/03 via certified return receipt requested. The envelope and letter are flagged 'IMPORTANT: Patient Management Information'. The letter recommends that physicians schedule an immediate follow-up visit with each of their patients implanted with an affected Belos VR or VR-T ICD to evaluate the device charge times. The firm provided the doctors with the names of their patients. |
| Quantity | 469 |
| Distribution | The firm distributed to physicians throughout the United States. The firm only distributes to US customers. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.