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

Recall Z-2419-2015 — Getinge 86 Series Washer/Disinfector with G1 control system software, Model 8666 and Model 8668. For use in healthcare facilities and laboratories where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.

U.S. FDA — Device Enforcement · Sweden · 2015-06-26 · Class III

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2419-2015
Date of alert: 2015-06-26
Country / jurisdiction: Sweden
Risk level: Class III
Risk type: recall
Brand: Getinge Disinfection Ab
Product category: device
Product type: Devices

Reported risk: Getinge Disinfection AB has initiated a Field Correction due to the potential for unauthenticated remote access to the product over the network.

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.

Recall Z-2419-2015 — Getinge 86 Series Washer/Disinfector with G1 control system software, Model 8666 and Model 8668. For use in healthcare facilities and laboratories where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.

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