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

Recall Z-2266-2018 — CARESCAPE R860 ventilators with software version 10SP05 Product Usage: The CARESCAPE R860 ventilator is designed to provide mechanical ventilation or support to neonatal, pediatric, and adult patients weighing 0.25 kg and above. The CARESCAPE R860 ventilator is a microprocessor based, electronic

U.S. FDA — Device Enforcement · United States · 2017-12-08 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2266-2018
Date of alert: 2017-12-08
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Datex-Ohmeda, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 103841473

Reported risk: Potential for the display processor to experience an unexpected failure.

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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