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

Recall Z-2441-2020 — DIRECT SUPPLY Attendant VITAL SIGNS MONITOR, REF AVSM2 - Product Usage: It is vital sign monitor to monitor noninvasive blood pressure (NIBP), functional arterial oxygen saturation (SpO2), pulse rate (PR), temperature (Temp) for adult, pediatric and neonatal patients in all areas of a hospital and h

U.S. FDA — Device Enforcement · Korea (the Republic of) · 2020-05-15 · 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-2441-2020
Date of alert: 2020-05-15
Country / jurisdiction: Korea (the Republic of)
Risk level: Class II
Risk type: recall
Brand: Mediana Co., Ltd.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 456802000001

Reported risk: Failures were found in the temperature measurement function while in the predict mode.

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