Drug recall
Shape-HF Cardiopulmonary Testing System Disposable Patient Interface (DPI). Part Number 0004-4001. The…
FDA recall event 70149 · Class II · Shape Medical Systems, Inc
Key facts
| Event ID | 70149 |
|---|---|
| Recall numbers | Z-1060-2015 |
| Recalling firm | Shape Medical Systems, Inc |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Dec 23, 2014 |
| Report date | Feb 11, 2015 |
| Termination date | Apr 14, 2015 |
| City | Saint Paul |
| State | MN |
| Country | United States |
| FEI number | 3008072932 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: