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

Recall Z-2114-2014 — GE Healthcare, CARESCAPE Monitor B650. A multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility.

U.S. FDA — Device Enforcement · United States · 2014-07-07 · 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-2114-2014
Date of alert: 2014-07-07
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: GE Healthcare, LLC
Product category: device
Product type: Devices

Reported risk: Possible sound loss associated with the CARESCAPE Monitor B650. When an external display is connected to the CARESCAPE Monitor B650 using a USB extender cable with an active USB hub, the system may experience a sound loss including alarm sounds from the patient monitor. This may occur if the external display is powered off and on during normal operation of the monitor.

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-2114-2014 — GE Healthcare, CARESCAPE Monitor B650. A multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility.

Related