Recall Z-1060-2015 ยท BTY Calculator, Predicted Values, Pulmonary Function
Shape Medical Systems, Inc
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.
| Date | Feb 5, 2015 (initiated Dec 23, 2014) |
| 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. |
| Root cause | Under Investigation by firm |
| Action | An Urgent Medical Device Recall letter was mailed to consignees on 12/23/2014. The letter identified affected product, described the issue and asked for product to be returned. Shape Technical Service will contact customers to assist in the return of product. A response form was asked to be returned. Customers with questions can call Shape Technical Service at 1-888-906-6266. |
| Quantity | 564 devices |
| Distribution | Distributed in the states of AZ, FL, GA, MA, MN, NJ. NY, PA, TX, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090722 | SHAPE-HF CARDIOPULMONARY EXERCISE TESTING SYSTEM Shape Medical Systems, Inc., Mar 31, 2009 |