Z-0304-2012

Ambulatory Blood Pressure (ABP) Monitor, Model 90217A. The Spacelabs Model 90217A Ambulatory Blood Pressure...

Name: Z-0304-2012 Ambulatory Blood Pressure (ABP) Monitor, Model 90217A. The Spacelabs Model 90217A Ambulatory Blood Pressure...
Creator: Del Mar Reynolds Medical, Ltd.
Published: 2011-10-12
License: https://open.fda.gov/license/

GE Healthcare / initiated 2011-10-12 / Terminated / root cause: design

FDA source

Del Mar Reynolds Medical, Ltd. began a recall of Ambulatory Blood Pressure (ABP) Monitor, Model 90217A. The Spacelabs Model 90217A Ambulatory Blood Pressure (ABP) Monitor is a small, lightweight unit designed... on 2011-10-12. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0304-2012
Status: Terminated
Initiated: 2011-10-12
Posted: 2011-11-29
Terminated: 2012-05-30
Recalling firm: GE Healthcare
Product: 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.
Product code: DXN System, Measurement, Blood-Pressure, Non-Invasive
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.
Root cause tag: design
FDA 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 1-800-522-7025, select 2 for Technical support for any question about this recall.
Quantity in commerce: 785 units worldwide (83 in US and 702 outside US)
Distribution: Worldwide Distribution
Product codes and lots: Serial Numbers: 217A-000001, 217A-000013, 217A-000017, 217A-000018, 217A-000019, 217A-000020, 217A-000021, 217A-000022, 217A-000026, 217A-000027, 217A-000028, 217A-000029, 217A-000032, 217A-000033, 217A-000034, 217A-000035, 217A-000036, 217A-000037, 217A-000038, 217A-000039, 217A-000040, 217A-000041, 217A-000042, 217A-000043, 217A-000044, 217A-000045, 217A-000046, 217A-000047, 217A-000048, 217A-000049, 217A-000050, 217A-000051, 217A-000052, 217A-000055, 217A-000056, 217A-000057, 217A-000058, 217A-000059, 217A-000060, 217A-000066, 217A-000068, 217A-000069, 217A-000070, 217A-000071, 217A-000072, 217A-000073, 217A-000074, 217A-000075, 217A-000076, 217A-000077, 217A-000078, 217A-000079, 217A-000080, 217A-000081, 217A-000082, 217A-000083, 217A-000084, 217A-000085, 217A-000086, 217A-000087, 217A-000088, 217A-000089, 217A-000090, 217A-000091, 217A-000092, 217A-000093, 217A-000094, 217A-000095, 217A-000096, 217A-000103, 217A-000104, 217A-000105, 217A-000106, 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Product code DXN

K103732Class IISpacelabs Model 90217A Ambulatory Blood Pressure (Abp) MonitorSpacelabs Healthcare, Ltd. / cleared 2011-02-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)