Ambulatory Blood Pressure (ABP) Monitor, Model 90217A. The Spacelabs Model 90217A Ambulatory Blood Pressure (ABP) Monito
FDA device recall Z-0304-2012 · posted 2011-11-29 · Terminated
Recall details
- Recalling firm
- Del Mar Reynolds Medical, Ltd.
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- DXN
- Quantity affected
- 785 units worldwide (83 in US and 702 outside US)
- Distribution
- Worldwide Distribution
- Date initiated
- 2011-10-12
- Date posted
- 2011-11-29
- Date terminated
- 2012-05-30
- Location
- Hertford, United Kingdom
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SPACELABS MODEL 90217A AMBULATORY BLOOD PRESSURE (ABP) MONITOR (K103732) | Spacelabs Healthcare, Ltd. | 2011-02-04 |