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

Recall Z-0388-2019 — DeltaVision OMX SR Imaging System Model Number: 29115476 The DeltaVision OMX SR Imaging System is a piece of laboratory equipment for super resolution imaging offluorescently-la beling biological samples. Techniques such as 3D Structured Illumination, Total Internal Reflection Fluorescence and l

U.S. FDA — Device Enforcement · United States · 2018-09-10 · Class II

AI-assisted, human-edited — this page is drafted with AI from public-source data, then reviewed before publication. How we use AI →

Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0388-2019
Date of alert: 2018-09-10
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: GE Healthcare Biosciences
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 29115476

Reported risk: Non-conformance with the DeltaVision OMX SR, the interlocks are not wired in a redundant fashion to make the interlock system single-fault tolerant.

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.

Related