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

Recall Z-1060-2015 — Shape-HF Cardiopulmonary Testing System Disposable Patient Interface (DPI). Part Number 0004-4001. The Shape-HF Cardiopulmonary Exercise Testing System is a stationary device that monitors parameters during laboratory or clinical conditions.

U.S. FDA — Device Enforcement · United States · 2014-12-23 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1060-2015
Date of alert: 2014-12-23
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Shape Medical Systems, Inc
Product category: device
Product type: Devices

Reported risk: This recall has been initiated because use of the impacted DPIs could result in erroneous testing results potentially leading to incorrect diagnosis and incorrect treatment. The magnitude of error for VO2 or VCO2 parameters could be approximately 20% with use of the impacted product.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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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-1060-2015 — Shape-HF Cardiopulmonary Testing System Disposable Patient Interface (DPI). Part Number 0004-4001. The Shape-HF Cardiopulmonary Exercise Testing System is a stationary device that monitors parameters during laboratory or clinical conditions.

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