Shape-HF Cardiopulmonary Testing System Disposable Patient Interface (DPI). Part Number 0004-4001. The Shape-HF Cardiopu
FDA device recall Z-1060-2015 · posted 2015-02-05 · Terminated
Recall details
- Recalling firm
- Shape Medical Systems, Inc
- 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.
- Action taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- BTY
- Quantity affected
- 564 devices
- Distribution
- Distributed in the states of AZ, FL, GA, MA, MN, NJ. NY, PA, TX, and WI.
- Date initiated
- 2014-12-23
- Date posted
- 2015-02-05
- Date terminated
- 2015-04-14
- Location
- Saint Paul, MN
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SHAPE-HF CARDIOPULMONARY EXERCISE TESTING SYSTEM (K090722) | Shape Medical Systems, Inc. | 2009-03-31 |