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

Recall Z-0806-2020 — Kodak DirectView DR3000/3500 - Product Usage: permanently installed as a diagnostic system intended to generate and control x-rays for examination of various anatomical regions. The DR Operator Console is the user interface. All operator functions except positioning the Bucky assembly and controls f

U.S. FDA — Device Enforcement · United States · 2020-01-06 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0806-2020
Date of alert: 2020-01-06
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Carestream Health, Inc.
Product category: device
Product type: Devices

Reported risk: Carestream Health has discovered a potential safety problem that can lead to unintended movement of the U-Arm.

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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