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

Recall Z-2060-2018 — Sonialvision Safire II, Model #: DAR-8000f Product Usage: This angiographic x-ray system device intended to be used for the radiography in the hospital with X-ray devices. This device is operated and used by the physicians and X-ray technologist. The object of this device is total patient popul

U.S. FDA — Device Enforcement · United States · 2018-01-12 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2060-2018
Date of alert: 2018-01-12
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Shimadzu Medical Systems
Product category: device
Product type: Devices

Reported risk: When selecting serial radiography with a pulse rate of 7.5fps (including selecting a preset or changing the pulse rate using a temporary edit function) it was observed the indicated "irradiation time" on the X-ray Generator Console, as well as the "integral dose" on the external console of fluoroscopy, were reset to 0. There has been one report of this event.

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

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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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