Recall Z-2051-2014 ยท BTY Calculator, Predicted Values, Pulmonary Function
Shape Medical Systems, Inc
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.
| Date | Jul 14, 2014 (initiated May 28, 2014) |
| 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. |
| Root cause | Under Investigation by firm |
| Action | Shape Medical Systems sent an Urgent Medical Device Correction letter dated June 17, 2014, to all affected customers. Customers were informed that new orders of the Disposable Patient interface devices (DPI) will require a software upgrade for the Shape HF Cardiopulmonary Testing System prior to using the new DPIs. Impacted DPIs will be shipped with Instructions to conduct the software upgrade and Technical Service will contact customers shipped the impacted DPIs to confirm receipt and assist with the software upgrade. A Response Form was requested to be returned. Customers with questions |
| Quantity | 800 |
| Distribution | Nationwide Distribution |
| 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 |