Recall Z-0144-2008 ยท HIG Insufflator, Hysteroscopic
Karl Storz Endoscopy America Inc
Storz Equipment, Fluid Management Stand, for Fluid Management Systems, Product Number 26601EQ-KT
| Date | Nov 7, 2007 (initiated Aug 17, 2007) |
| Status | Terminated |
| Reason | Outflow Difference: The accuracy of the Equimat displayed value could be influenced by external factors of the cart/stand and may result in a fluctuating or inaccurate reading. |
| Root cause | Device Design |
| Action | All affected customers were notified via a Customer Letter issued on September 10, 2007 via FedEx overnight mail. The letter describes the problem with the device and the health hazard risk, and provides instructions for users to return the old stand and make arrangements for replacement stands. |
| Quantity | 287 |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.