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

Recall Z-1118-2017 — Mammomat Inspiration full, field digital,system,x-ray,mammographic Product Usage: The Mammomat Inspiration system is intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals. Mammographic images can be interpreted by either ha

U.S. FDA — Device Enforcement · United States · 2017-01-11 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1118-2017
Date of alert: 2017-01-11
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): 10140000

Reported risk: Software error

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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