Devices

Device Recall Shape Disposable Patient Interface

Model / Serial
Lot Numbers: 1412001, 1412002, 1412003 and 1412004
Product Classification
Anesthesiology Devices
Device Class
2
Implanted device?
No
Distribution
Distributed in the states of AZ, FL, GA, MA, MN, NJ. NY, PA, TX, and WI.
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.
Manufacturer
Shape Medical Systems, Inc
1 Event
- Recall of Device Recall Shape Disposable Patient Interface

Manufacturer

Shape Medical Systems, Inc

Manufacturer Address
Shape Medical Systems, Inc, 5000 Township Pkwy, Saint Paul MN 55110-5852
Manufacturer Parent Company (2017)
Shape Medical Systems Inc.
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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