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

Infinity Acute Care System (lACS) Monitoring Solution; Catalog Numbers:MS20401, MS20724, MS22956, MS25510, MS25520, MS25643, MS26196, MS26372, MS31818; UDI Information: 4049098054454, 4049098054447, 4049098054409, 4049098009799, 4049098009751. Multi-parameter, physiologic patient monitoring o — recall Z-1813-2018

U.S. FDA — Device Enforcement · United States · 2018-03-28 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1813-2018
Date of alert: 2018-03-28
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Draegar Medical Systems, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 4049098054454

Reported risk: Software anomaly resulting in the loss of patient settings and stored patient data.

Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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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