Recall Z-1060-2015— Shape Medical Systems, Inc
Class II · Terminated
Class II FDA medical device recall by Shape Medical Systems, Inc, initiated 2014-12-23, terminated 2015-04-14. It names one FDA 510(k) clearance: K090722. 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: 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..
- Recalling firm
- Shape Medical Systems, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-12-23
- Terminated
- 2015-04-14
- Firm location
- Saint Paul, MN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.