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

Oasis Coil Extension Cable used with Hitachi Oasis MRI System Product Usage: The Oasis MR system is an imaging device and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The Oasis system produces — recall Z-2366-2015

U.S. FDA — Device Enforcement · United States · 2014-04-25 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2366-2015
Date of alert: 2014-04-25
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Hitachi Medical Systems America Inc
Product category: device
Product type: Devices

Reported risk: The firm received a complaint stating the Coil Extension Cable accessory would overheat and be a burn hazard if touched.

Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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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