Shape Medical Systems, Inc: Medical Device Recall in 2015 - (Recall #: Z-1060-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: December 23, 2014

Date Posted: February 11, 2015

Recall Number: Z-1060-2015

Event ID: 70149

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.

Status: Terminated

Product Quantity: 564 devices

Code Information:

Lot Numbers: 1412001, 1412002, 1412003 and 1412004

Distribution Pattern:

Distributed in the states of AZ, FL, GA, MA, MN, NJ. NY, PA, TX, and WI.

Voluntary or Mandated:

Voluntary: Firm initiated