Z-1060-2015Class II

Shape-HF Cardiopulmonary Testing System Disposable Patient Interface (DPI). Part Number 0004-4001. The...

Name: Z-1060-2015 Shape-HF Cardiopulmonary Testing System Disposable Patient Interface (DPI). Part Number 0004-4001. The...
Creator: Shape Medical Systems, Inc
Published: 2014-12-23
License: https://open.fda.gov/license/

Shape Medical Systems, Inc / initiated 2014-12-23 / Terminated

FDA source

Shape Medical Systems, Inc began a recall of Shape-HF Cardiopulmonary Testing System Disposable Patient Interface (DPI). Part Number 0004-4001. The Shape-HF Cardiopulmonary Exercise Testing System is a... on 2014-12-23. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1060-2015
Classification: Class II
Status: Terminated
Initiated: 2014-12-23
Posted: 2015-02-05
Terminated: 2015-04-14
Recalling firm: Shape Medical Systems, Inc
Product: 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 code: BTY Calculator, Predicted Values, Pulmonary Function
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.
FDA root cause: Under Investigation by firm
Action: An Urgent Medical Device Recall letter was mailed to consignees on 12/23/2014. The letter identified affected product, described the issue and asked for product to be returned. Shape Technical Service will contact customers to assist in the return of product. A response form was asked to be returned. Customers with questions can call Shape Technical Service at 1-888-906-6266.
Quantity in commerce: 564 devices
Distribution: Distributed in the states of AZ, FL, GA, MA, MN, NJ. NY, PA, TX, and WI.
Product codes and lots: Lot Numbers: 1412001, 1412002, 1412003 and 1412004

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1060-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1060-2015	Class II	Terminated	Voluntary: Firm initiated	2015-02-11	2015-02-05

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)