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

Recall Z-2873-2018 — GE Healthcare Optima CT660. The systems are intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. Sold only outside the U.S. under the following product names: CT OPTIMA 660, CT OPTIMA 660 LONG BJG SKD RUS, CT OPTIMA 660 LONG BJG SKD RUSSIA, CT OPTIMA 660 MI

U.S. FDA — Device Enforcement · Japan · 2018-04-27 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2873-2018
Date of alert: 2018-04-27
Country / jurisdiction: Japan
Risk level: Class II
Risk type: recall
Brand: GE Healthcare Japan Corporation
Product category: device
Product type: Devices

Reported risk: GE Healthcare has identified that some CT systems may have a damaged cable that can expose 120VAC to Service Engineers working inside the gantry.

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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