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

Recall Z-0837-2015 — DPM 6 Patient Monitor and DPM 7 Patient Monitor. The product affected is the Mindray IBP module, P/N is 6800-30-50485 for use with Mindray DPM 6 and DPM 7 patient monitors . Intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters.

U.S. FDA — Device Enforcement · United States · 2014-10-06 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0837-2015
Date of alert: 2014-10-06
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Mindray DS USA, Inc. dba Mindray North America
Product category: device
Product type: Devices

Reported risk: Mindray has identified an issue that involves the IBP module used with the DPM 6 and DPM 7 Monitor where the IBP measurement data may be displayed in an incorrect IBP tile on the monitors display.

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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