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.
FDA Recall Z-0304-2012 · Posted 2011-11-29
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Recalling FirmDel Mar Reynolds Medical, Ltd.
Recall StatusTerminated
Product CodeDXN
Date Initiated2011-10-12
Date Terminated2012-05-30
Product Quantity785 units worldwide (83 in US and 702 outside US)
Reason for Recall
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.
Firm 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 1-800-522-7025, select 2 for Technical support for any question about this recall.
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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