Shape-HF Cardiopulmonary Testing System Disposable Patient Interface — Class II medical device recall Z-1060-2015
Terminated recall by Shape Medical Systems, Inc, reported 2015-02-11, distributed in AZ, FL, GA, MA, MN, NJ, NY, PA…. This recall has been initiated because use of the impacted DPIs could result in erroneous testing results pote
| Recall number | Z-1060-2015 |
|---|---|
| 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 | 2014-12-23 |
| Classified | 2015-02-05 |
| Reported by FDA | 2015-02-11 |
| Terminated | 2015-04-14 |
| Distributed | AZ, FL, GA, MA, MN, NJ, NY, PA, TX, WI |
| Quantity | 564 devices |
| Lot numbers | 1412001, 1412002, 1412003, 1412004 |
| Model numbers | 0004-4001 |
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.
Reason for recall
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.
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-1060-2015. 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.