Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Shape HF Cardiopulmonary System. Made up of Shape HF System Recalled by Shape Medical Systems, Inc Due to Shape Medical has initiated a correction due to...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Shape Medical Systems, Inc directly.
Affected Products
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 variables are indicated. The system will provide physiological data to physicians to aid in patient assessment.
Quantity: 800
Why Was This Recalled?
Shape Medical has initiated a correction due to a mandatory software upgrade for the Shape HF Cardiopulmonary Testing System prior to use of the impacted DPI lot numbers. Use of the incorrect software version with the impacted DPIs could result in erroneous testing results potentially leading to incorrect diagnosis and incorrect treatment.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Shape Medical Systems, Inc
Shape Medical Systems, Inc has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report