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

Recall Z-1750-2022 — Surpria 64: Software Version V3.11, V3.22

U.S. FDA — Device Enforcement · United States · 2022-07-12 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1750-2022
Date of alert
2022-07-12
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
FUJIFILM Healthcare Americas Corporation
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
04573596200520
Reported risk: Error 00003050 or 00003052 may occur during scanning, the captured images will not be reconstructed and the Raw Data will not be displayed in the work list.result, may result in the need for additional scanning to capture the images properly for reconstruction, thereby exposing the patient to additional radiation
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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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.