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

Recall Z-0534-2021 — Shimadzu Mobile X-Ray System, MobileDaRt Evolution (MX8 Version), with adjustable handle option, Made in Japan - Product Usage: The device is intended to be used to take a film, CR or general radiography of patients in the hospital who cannot move and/or of outpatients in emergency.

U.S. FDA — Device Enforcement · United States · 2020-11-09 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0534-2021
Date of alert: 2020-11-09
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Shimadzu Medical Systems
Product category: device
Product type: Devices

Reported risk: There is a potential that the adjustable handle option on the X-Ray system may have been installed with improper bolts. This could result in improper driving operation which could lead to harm of individuals around the device.

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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