Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported February 11, 2015
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.
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…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Shape Medical Systems, Inc recalled Shape-HF Cardiopulmonary Testing System Disposable Patient Interface (DPI). Part Number… - a moderate-severity action.
Shape-HF Cardiopulmonary Testing System Disposable Patient Interface (DPI). Part Number… was recalled by Shape Medical Systems, Inc in February 11, 2015. Reason: This recall has been initiated because use of the impacted DPIs could result in erroneous testing results pot…. Check the official notice for the remedy. Verify recall #Z-1060-2015 with the FDA Devices before acting.
The recall
Shape Medical Systems, Inc issued this moderate-severity FDA Devices recall-This recall has been initiated because use of the impacted DPIs could result in erroneous testing results pot….
- Moderate
- severity level
- 564 units
- affected scope
- Class II
- classification
- February 11, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1060-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1060-2015) was formally reported on February 11, 2015, with the manufacturer initiating the action on December 23, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Shape Medical Systems, Inc is listed as the recalling firm, operating out of Saint Paul, MN. Federal records list the affected scope as 564 devices.
The documented reason for this recall is: 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 parame… Distribution data in the federal record shows the product reached: Distributed in the states of AZ, FL, GA, MA, MN, NJ. NY, PA, TX, and WI.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
564 devices
Related Recalls
6
3 from same agency
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.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1060-2015 |
| Date reported | February 11, 2015 |
| Date initiated | December 23, 2014 |
| Recalling firm | Shape Medical Systems, Inc |
| Firm location | Saint Paul, MN |
| Affected scope | 564 devices |
| Distribution | Distributed in the states of AZ, FL, GA, MA, MN, NJ. NY, PA, TX, and WI. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1060-2015) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Shape Medical Systems, Inc. Units affected: 564 devices.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 11, 2015. Severity: Moderate. Recall number: Z-1060-2015.
Where was the recalled product distributed? ▼
Distribution: Distributed in the states of AZ, FL, GA, MA, MN, NJ. NY, PA, TX, and WI..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1060-2015) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported February 11, 2015. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.