Shape Medical Systems, Inc: Medical Device Recall in 2014 - (Recall #: Z-2051-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: May 28, 2014

Date Posted: July 23, 2014

Recall Number: Z-2051-2014

Event ID: 68581

Reason for Recall:

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.

Status: Terminated

Product Quantity: 800

Code Information:

DPIs with Lot Number 1405006 and higher.

Distribution Pattern:

Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated