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

Recall Z-1388-2019 — EDS Light Suspension, Central Axis, a component of the Stryker Visum LED Surgical Lighting System, with the following catalog numbers: 0682001286, EDS Light Suspension, Central Axis, 5P/FP; 0682001298, EDS Light Suspension, Central Axis, 5P; 0682001299, EDS Light Suspension, Central Axis, 5P/5P; 06

U.S. FDA — Device Enforcement · United States · 2018-11-13 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1388-2019
Date of alert: 2018-11-13
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Stryker Communications
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 0682001286

Reported risk: There is a potential the joint in the suspension of the device is insufficiently assembled.

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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