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

Recall Z-0405-2018 — Syngo Imaging version V31 (model # 10014063) is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images, including digital mammography images. It supports the physician in diagnosis and treatme

U.S. FDA — Device Enforcement · United States · 2017-07-25 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0405-2018
Date of alert: 2017-07-25
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Siemens Medical Solutions USA, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 10014063

Reported risk: Siemens is releasing a letter to inform about potential data loss relevant to diagnosis.

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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