International Medical Devices Database

Manufacturer Address
Shape Medical Systems, Inc, 5000 Township Pkwy, Saint Paul MN 55110-5852
Manufacturer Parent Company (2017)
Shape Medical Systems Inc.
Source
USFDA
2 Events
- Recall of Device Recall Shape HF Cardiopulmonary System
- Recall of Device Recall Shape Disposable Patient Interface

2 devices in the database

Device Recall Shape HF Cardiopulmonary System

Model / Serial
DPIs with Lot Number 1405006 and higher.
Product Classification
Anesthesiology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution
Product Description
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.

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.

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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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Shape Medical Systems, Inc

2 devices in the database

Device Recall Shape HF Cardiopulmonary System

Device Recall Shape Disposable Patient Interface