Shape Medical Systems Recalls Cardiopulmonary Testing System Patient Interfaces
Shape Medical Systems is recalling 564 disposable patient interfaces for the Shape-HF Cardiopulmonary Testing System because they may produce erroneous results, potentially leading to incorrect diagnosis and treatment.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 involves a risk-of-harm product where injury has not yet been reported, as the source states the devices could lead to incorrect diagnosis and treatment without mentioning specific injuries or illnesses.
Plain-English summary
Shape Medical Systems, Inc. is recalling 564 units of the Shape-HF Cardiopulmonary Testing System Disposable Patient Interface (DPI), Part Number 0004-4001. The affected lot numbers are 1412001, 1412002, 1412003, and 1412004. The devices were distributed in Arizona, Florida, Georgia, Massachusetts, Minnesota, New Jersey, New York, Pennsylvania, Texas, and Wisconsin.
The recall was initiated because the use of the impacted DPIs could result in erroneous testing results. The magnitude of error for VO2 or VCO2 parameters could be approximately 20% with the use of the impacted product. These erroneous results could potentially lead to incorrect diagnosis and incorrect treatment.
The source text does not specify instructions for consumers or healthcare providers on how to handle the recalled devices.
The recalled product
- Product
- 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.
- Manufacturer
- Shape Medical Systems, Inc
- Affected units
- 564
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 (3)
- Lot Numbers: 1412001
- 1412002
- 1412003 and 1412004
Distribution
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