Shape HF Cardiopulmonary System. Made up of Shape HF System Analyzer (PN 0001-9001) and Disposable Patient Interface (DP
FDA device recall Z-2051-2014 · posted 2014-07-14 · Terminated
Recall details
- Recalling firm
- Shape Medical Systems, Inc
- 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.
- Action taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- BTY
- Quantity affected
- 800
- Distribution
- Nationwide Distribution
- Date initiated
- 2014-05-28
- Date posted
- 2014-07-14
- Date terminated
- 2015-05-22
- Location
- Saint Paul, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SHAPE-HF CARDIOPULMONARY EXERCISE TESTING SYSTEM (K090722) | Shape Medical Systems, Inc. | 2009-03-31 |