Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2114-2017 — INTENSIA Models: VR 124, DR 154, CRT-D 174 Product Usage: OVATIO VR 6250, OVATIO DR 6550, PARADYM VR 8250, PARADYM DR 8550, PARADYM RF VR 9250, PARADYM RF DR 9550, INTENSIA VR 124 and INTENSIA DR 154 are indicated for use in patients who are at high risk of sudden cardiac death due to ventricul

U.S. FDA — Device Enforcement · Italy · 2017-04-11 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2114-2017
Date of alert: 2017-04-11
Country / jurisdiction: Italy
Risk level: Class II
Risk type: recall
Brand: Sorin Group Italia SRL - CRF
Product category: device
Product type: Devices

Reported risk: Sorin is notifying physicians that certain defibrillators' battery depletion may be undetectable.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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