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

Recall Z-0901-2015 — SenSmart, Regional Oximetry EQUANOX Classic Plus Adult/Pediatric Sensor > 40 kg., Model 8003CA (REF 9824-001, 3-Wavelength), 8004CA (REF 9705-001, 4-Wavelength), with associated materials (INT-100 cable, operator's manual; and Quick Start Guide). Sensors are single-packed in a pouch, then mult

U.S. FDA — Device Enforcement · United States · 2014-11-25 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0901-2015
Date of alert: 2014-11-25
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Nonin Medical, Inc
Product category: device
Product type: Devices

Reported risk: Nonin Medical is conducting a recall of certain regional oximetry sensors and associated products. They have received reports of signal loss during use of our shortcabled regional oximetry sensors with diaphoretic patients. No injury or illness have been reported.

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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