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

Recall Z-0823-2013 — GE Healthcare, CARESCAPE Monitor B650. The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. The CARESCAPE Monitor B650 is intended for use on adult, pediatric, and neonatal patien

U.S. FDA — Device Enforcement · United States · 2011-09-30 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0823-2013
Date of alert: 2011-09-30
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: GE Healthcare, LLC
Product category: device
Product type: Devices

Reported risk: GE Healthcare has become aware of potential issues associated with the CARESCAPE Monitor B650. There have been no reported illnesses or injuries that have occurred with the use of the device.

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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