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

Recall Z-2279-2023 — Field Upgrade Kits: P/N 5451208 RIU, 9 INCH, TOSHIBA; P/N 5485304 SERVICE PART, IMAGE INTENSIFIER, 9 INCH, TOSHIBA; P/N 5761613 SERVICE PART, IMAGE INTENSIFIER, 9 INCH - used with OEC Flexiview 8800, OEC 9800, and OEC 9900 Systems

U.S. FDA — Device Enforcement · United States · 2023-05-15 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2279-2023
Date of alert
2023-05-15
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
GE OEC Medical Systems, Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
80165102
Reported risk: Image intensifiers on systems, used to provide fluoroscopic/digital spot images can become detached if the systems encounter a large impact force when moved, which may result in the image intensifier falling, which could lead to injuries such as fractures, hematoma, contusion, bruise, pain.
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.

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