FDA Device recall Z-1060-2015
Shape-HF Cardiopulmonary Testing System Disposable Patient Interface (DPI). Part Number 0004-4001
- FDA Device
- Class II
- terminated
- Published 2015-02-11
On 2015-02-11 the FDA classified a Class II recall of Shape-HF Cardiopulmonary Testing System Disposable Patient Interface (DPI). Part Number 0004-4001 by Shape Medical Systems, citing 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 m….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1060-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-12-23 |
| Published | 2015-02-11 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Shape Medical Systems |
| Distribution | AZ, FL, GA, MA, MN, NJ, NY, PA, TX, WI |
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.
Reason
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.
Identifiers
| code_info | Lot Numbers: 1412001, 1412002, 1412003 and 1412004 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1060-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.