Date Initiated by Firm | April 09, 2009 |
Date Posted | July 07, 2009 |
Recall Status1 |
Terminated 3 on August 27, 2012 |
Recall Number | Z-1582-2009 |
Recall Event ID |
52223 |
510(K)Number | K050172 |
Product Classification |
circulatory assist device - Product Code DRN
|
Product | Cardiomedics CardiAssist External Counterpulsation System, circulatory assist device, Series 4000. |
Code Information |
CardioAssist Model 4000 Serial 4018 |
Recalling Firm/ Manufacturer |
Cardiomedics Incorporated 7 Whatney Suite B Irvine CA 92618-2839
|
For Additional Information Contact | 949-863-2500 |
Manufacturer Reason for Recall | Cuff may underinflate, or device may stop working during use. Cardioassist software version 4.3.1 utilized a signal from the plethysmograph that was found not to be sensitive enough due to the shape of the waveform in certain circumstances where there was excessive motion artifact. |
FDA Determined Cause 2 | Software design |
Action | Service visit to customer in May 2009 to upgrade and validate CardioAssist 4000 software to version 4.3.5. |
Quantity in Commerce | 1 |
Distribution | Florida |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database | 510(K)s with Product Code = DRN
|