High FDA (Devices)·Z-2051-2014·Announced 2014-07-23

Shape HF Cardiopulmonary System Recalled for Software Upgrade Requirement

Shape Medical Systems is recalling 800 Shape HF Cardiopulmonary Systems because a mandatory software upgrade is required before using specific Disposable Patient Interface lots to prevent erroneous testing results.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a risk of harm (incorrect diagnosis and treatment) due to erroneous testing results, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score.

Plain-English summary

Shape Medical Systems, Inc. has initiated a correction for the Shape HF Cardiopulmonary System, which consists of the Shape HF System Analyzer and Disposable Patient Interface (DPI). The recall affects 800 units distributed nationwide. The issue involves DPIs with Lot Number 1405006 and higher.

The recall is necessary because a mandatory software upgrade is required for the Shape HF Cardiopulmonary Testing System prior to the use of the impacted DPI lot numbers. Using the incorrect software version with these specific DPIs could result in erroneous testing results. These errors potentially lead to incorrect diagnosis and incorrect treatment for patients undergoing cardiopulmonary exercise testing.

Healthcare providers and facilities using the Shape HF Cardiopulmonary System should ensure the mandatory software upgrade is completed before using any Disposable Patient Interfaces with Lot Number 1405006 or higher. The system provides physiological data to physicians to aid in patient assessment, so accurate software operation is critical for valid results.

The recalled product

Product: Shape HF Cardiopulmonary System. Made up of Shape HF System Analyzer (PN 0001-9001) and Disposable Patient Interface (DPI), (PN 0004-4001). A pulmonary gas exchange testing system used during cardiopulmonary exercise testing where collection and review of gas exchange variable
Manufacturer: Shape Medical Systems, Inc
Category: Medical Device — Cardiopulmonary Testing
Hazard: erroneous-results
incorrect-diagnosis
incorrect-treatment
Affected units: 800

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

DPIs with Lot Number 1405006 and higher.

Distribution

Distributed nationwide across the United States.

Same manufacturer · Shape Medical Systems, Inc

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High
Shape Medical Systems Recalls Cardiopulmonary Testing System Patient Interfaces
FDA (Devices) · 2015-02-11

Same hazard · erroneous results