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

Recall Z-0092-2021 — Servo-i Ventilator, Part No. 6487800, UDI Code 07325710000823 - Product Usage: intended for general and critical ventilator care, and it can be used for low end to high end intensive care, in different configurations. It supports a variety of breathing modes and can be used for Neonates, Pediatric a

U.S. FDA — Device Enforcement · United States · 2020-09-17 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0092-2021
Date of alert: 2020-09-17
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Getinge Group Logistics America, LLC
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 07325710000823

Reported risk: A potentially shorter than specified nebulizer connector may result in difficulty in installing the Aeroneb Nebulizer module to the Servo-i device successfully.

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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