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 | 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. |
| 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 variables are indicated. The system will provide physiological data to physicians to aid in patient assessment. |
| Quantity | 800 |
| Distribution | Nationwide Distribution |
| Initiated | 2014-05-28 |
| Classified | 2014-07-14 |
| Terminated | 2015-05-22 |
| Recall number | Z-2051-2014 |
| 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-2051-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/68581/
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