Shape HF Cardiopulmonary System — Class II medical device recall Z-2051-2014
Terminated recall by Shape Medical Systems, Inc, reported 2014-07-23, distributed nationwide. Shape Medical has initiated a correction due to a mandatory software upgrade for the Shape HF Cardiopulmonary
| Recall number | Z-2051-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Shape Medical Systems, Inc, Saint Paul, MN, United States |
| Recall initiated | 2014-05-28 |
| Classified | 2014-07-14 |
| Reported by FDA | 2014-07-23 |
| Terminated | 2015-05-22 |
| Distributed | Nationwide (US) |
| Quantity | 800 |
| Reason classes | software |
| Lot numbers | 1405006 |
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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2051-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.