Class II — Shape Medical Systems, Inc
| Recalling firm | Shape Medical Systems, Inc |
|---|---|
| Registered facility | SHAPE MEDICAL SYSTEMS, INC (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| 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. |
| Quantity | 564 devices |
| Distribution | Distributed in the states of AZ, FL, GA, MA, MN, NJ. NY, PA, TX, and WI. |
| Initiated | 2014-12-23 |
| Classified | 2015-02-05 |
| Terminated | 2015-04-14 |
| Recall number | Z-1060-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Shape Medical Systems, Inc (Z-1060-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/70149/
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