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

Recall Z-0113-2020 — Achilles Express Bone Sonometer

U.S. FDA — Device Enforcement · United States · 2019-09-03 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0113-2020
Date of alert
2019-09-03
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
GE Healthcare, LLC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
828330086
Reported risk: Certain Achilles Express and Achilles Insight systems were shipped with European CEE-7/7 Type Power Cords to countries where three protruding pin plugs are required for protective earth connection.
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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