Recall Z-0304-2012 ยท DXN System, Measurement, Blood-Pressure, Non-Invasive
Del Mar Reynolds Medical, Ltd.
Ambulatory Blood Pressure (ABP) Monitor, Model 90217A. The Spacelabs Model 90217A Ambulatory Blood Pressure (ABP) Monitor is a small, lightweight unit designed to take blood pressure and heart rate measurements for a 24 hour, 48 hour, or longer period.
| Date | Nov 29, 2011 (initiated Oct 12, 2011) |
| Status | Terminated |
| Reason | If external pressure is applied to the cuff of the Ambulatory Blood Pressure, Model 90217A, during deflation, the monitor will stop working and display an EC75 error code. |
| Root cause | Device Design |
| Action | On October 21, 2011, a Medial Device Correction customer letter was mailed to all US customers. A return receipt was requested. The letter identified the affected devices and described the problem. If the device displays an EC75 error code, customers can cycle the power off and then on to restore normal functionality. Please advise patients of this mitigation to avoid a delay in obtaining results. The firm is in the process of upgrading their software to avoid the issue and will contact customers to arrange for an update to their monitors. Customers can call Spacelabs Healthcare at 1-800- |
| Quantity | 785 units worldwide (83 in US and 702 outside US) |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103732 | SPACELABS MODEL 90217A AMBULATORY BLOOD PRESSURE (ABP) MONITOR Spacelabs Healthcare, Ltd., Feb 4, 2011 |