Z-2051-2014Class II

Shape HF Cardiopulmonary System. Made up of Shape HF System Analyzer (PN 0001-9001) and Disposable Patient...

Name: Z-2051-2014 Shape HF Cardiopulmonary System. Made up of Shape HF System Analyzer (PN 0001-9001) and Disposable Patient...
Creator: Shape Medical Systems, Inc
Published: 2014-05-28
License: https://open.fda.gov/license/

Shape Medical Systems, Inc / initiated 2014-05-28 / Terminated / root cause: software

FDA source

Shape Medical Systems, Inc began a recall of 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... on 2014-05-28. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2051-2014
Classification: Class II
Status: Terminated
Initiated: 2014-05-28
Posted: 2014-07-14
Terminated: 2015-05-22
Recalling firm: Shape Medical Systems, Inc
Product: 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 code: BTY Calculator, Predicted Values, Pulmonary Function
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.
Root cause tag: software
FDA root cause: Under Investigation by firm
Action: Shape Medical Systems sent an Urgent Medical Device Correction letter dated June 17, 2014, to all affected customers. Customers were informed that new orders of the Disposable Patient interface devices (DPI) will require a software upgrade for the Shape HF Cardiopulmonary Testing System prior to using the new DPIs. Impacted DPIs will be shipped with Instructions to conduct the software upgrade and Technical Service will contact customers shipped the impacted DPIs to confirm receipt and assist with the software upgrade. A Response Form was requested to be returned. Customers with questions were instructed to call Shape Technical Service at 1-888-906-6266 or 651-621-2990.
Quantity in commerce: 800
Distribution: Nationwide Distribution
Product codes and lots: DPIs with Lot Number 1405006 and higher.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2051-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2051-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-23	2014-07-14

Product code BTY

K090722Class IIShape-HF Cardiopulmonary Exercise Testing SystemShape Medical Systems, Inc. / cleared 2009-03-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)