Recall Z-1813-2010 ยท DSP System, Balloon, Intra-Aortic And Control
Datascope Corporation
System 98XT/98 Intra-Aortic Balloon Pump This product was only distributed in India and Hong Kong/China.
| Date | Jun 21, 2010 (initiated May 10, 2010) |
| Status | Terminated |
| Reason | Certain MAQUET/Datascope Intra-Aortic Balloon Pumps (IABP) have the potential to experience display related issues. Although the IABP continues to deliver therapy to the patient, display related issues may cause the user to be unable to view the IABP on the information screen. |
| Root cause | Other |
| Action | Medical Device Recall Letters were sent to Hospital Administrators beginning May 10, 2010 by overnight mail. Customers with questions are directed to contact your local Sales/Service Representative or the company representative at 973-244-6314. |
| Quantity | 161 units total |
| Distribution | Class 2 - Worldwide distribution -- US and Distribution to Australia, Belarus, Belgium, Canada, Egypt, England, Germany, Hong Kong, India, Iran, Israel, Japan, Kuwait, Latvia, Lebanon, Serbia, Singapore, Spain, Switzerland, Turkey, Venezuela. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.