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

Recall Z-1203-2017 — The Schiller PB 1000, also known as: Merge Hemo Patient Data Module (PDM), V2 model, a major component of the Merge Hemo software.

U.S. FDA — Device Enforcement · United States · 2015-05-31 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1203-2017
Date of alert: 2015-05-31
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Merge Healthcare, Inc.
Product category: device
Product type: Devices

Reported risk: Non-invasive blood pressure pumps (NIBP) voltage is not sufficient and causes the NIBP pumps to fail prior to reaching adequate initial pressure.

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-1203-2017 — The Schiller PB 1000, also known as: Merge Hemo Patient Data Module (PDM), V2 model, a major component of the Merge Hemo software.

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