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

CARESCAPE PDM-Masimo SpO2. Physiological data monitor. — recall Z-2139-2021

U.S. FDA — Device Enforcement · United States · 2021-05-21 · Class II

As described by U.S. FDA — Device Enforcement: CARESCAPE PDM-Masimo SpO2. Physiological data monitor.

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2139-2021
Date of alert
2021-05-21
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
GE Healthcare, LLC
Product category
device
Product type
Devices
Recall status
Ongoing — the recall is still in progress
Initiated by
Voluntary: Firm initiated
Distribution
worldwide distribution US nationwide, Albania, Algeria, Argentina, Australia, Austria, Bahamas, Bahrain, Belgium, Bermuda, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Fij
Reported risk: Masimo SpO2 Saturation Values can become frozen after an extended length of use without a power down.
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.

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