Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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

FDA Recall Z-1203-2017 · Posted None

Recalling FirmMerge Healthcare, Inc.
Recall StatusTerminated
Product CodeDQK
Date Initiated2015-05-31
Date Terminated2020-03-13
Product Quantity341 sites potentially have the affected product versions

Reason for Recall

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

Firm Action

The recalling firm issued letters via email dated 3/28/2016 and 7/11/2016, or via certified mail if no email address was available. A third letter dated 1/23/2017 was also issued..

Root Cause

Nonconforming Material/Component

Distribution Pattern

Distribution was nationwide to medical facilities. There was also military and government distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K082421HEARTSUITE HEMODYNAMICS 7.10Emageon, Inc. · 2008-12-17

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑