Class 2 Device Recall Ambulatory Blood Pressure (ABP) Monitor

• Date Initiated by Firm: October 12, 2011
• Date Posted: November 29, 2011
• Recall Status: Terminated on May 30, 2012
• Recall Number: Z-0304-2012
• Recall Event ID: 60204
• 510(K)Number: K103732
• Product Classification: System, measurement, blood-pressure, non-invasive - Product Code DXN
• 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.
• Code Information: 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, 217A-000107, 217A-000108, 217A-000109, 217A-000110, 217A-000111, 217A-000112, 217A-000113, 217A-000114, 217A-000115, 217A-000116, 217A-000117, 217A-000118, 217A-000119, 217A-000120, 217A-000121, 217A-000122, 217A-000123, 217A-000124, 217A-000125, 217A-000126, 217A-000127, 217A-000128, 217A-000129, 217A-000130, 217A-000131, 217A-000132, 217A-000133, 217A-000134, 217A-000135, 217A-000136, 217A-000137, 217A-000138, 217A-000139, 217A-000140, 217A-000141, 217A-000142, 217A-000143, 217A-000144, 217A-000145, 217A-000146, 217A-000147, 217A-000148, 217A-000149, 217A-000150, 217A-000151, 217A-000152, 217A-000153, 217A-000154, 217A-000155, 217A-000156, 217A-000157, 217A-000158, 217A-000159, 217A-000160, 217A-000161, 217A-000162, 217A-000163, 217A-000164, 217A-000165, 217A-000166, 217A-000167, 217A-000168, 217A-000169, 217A-000170, 217A-000171, 217A-000172, 217A-000173, 217A-000174, 217A-000175, 217A-000176, 217A-000177, 217A-000178, 217A-000179, 217A-000180, 217A-000181, 217A-000182, 217A-000183, 217A-000184, 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217A-000512, 217A-000513, 217A-000514, 217A-000515, 217A-000516, 217A-000517, 217A-000518, 217A-000519, 217A-000520, 217A-000521, 217A-000522, 217A-000524, 217A-000525, 217A-000526, 217A-000527, 217A-000528, 217A-000529, 217A-000532, 217A-000534, 217A-000535, 217A-000536, 217A-000538, 217A-000539, 217A-000540, 217A-000541, 217A-000542, 217A-000543, 217A-000544, 217A-000545, 217A-000546, 217A-000547, 217A-000548, 217A-000550, 217A-000551, 217A-000552, 217A-000553, 217A-000554, 217A-000555, 217A-000556, 217A-000557, 217A-000558, 217A-000559, 217A-000560, 217A-000561, 217A-000562, 217A-000563, 217A-000564, 217A-000565, 217A-000566, 217A-000567, 217A-000568, 217A-000570, 217A-000571, 217A-000572, 217A-000573, 217A-000574, 217A-000584, 217A-000585, 217A-000586, 217A-000587, 217A-000588, 217A-000589, 217A-000590, 217A-000591, 217A-000592, 217A-000593, 217A-000594, 217A-000595, 217A-000596, 217A-000597, 217A-000598, 217A-000599, 217A-000600, 217A-000601, 217A-000602, 217A-000603, 217A-000604, 217A-000605, 217A-000606, 217A-000608, 217A-000609, 217A-000610, 217A-000611, 217A-000612, 217A-000614, 217A-000615, 217A-000616, 217A-000617, 217A-000618, 217A-000619, 217A-000620, 217A-000621, 217A-000622, 217A-000623, 217A-000624, 217A-000626, 217A-000627, 217A-000628, 217A-000629, 217A-000630, 217A-000631, 217A-000632, 217A-000633, 217A-000634, 217A-000635, 217A-000636, 217A-000637, 217A-000638, 217A-000639, 217A-000640, 217A-000641, 217A-000642, 217A-000643, 217A-000644, 217A-000645, 217A-000646, 217A-000647, 217A-000648, 217A-000649, 217A-000650, 217A-000651, 217A-000652, 217A-000654, 217A-000655, 217A-000656, 217A-000657, 217A-000658, 217A-000659, 217A-000660, 217A-000661, 217A-000662, 217A-000663, 217A-000664, 217A-000665, 217A-000666, 217A-000667, 217A-000668, 217A-000669, 217A-000670, 217A-000671, 217A-000672, 217A-000673, 217A-000674, 217A-000675, 217A-000676, 217A-000677, 217A-000678, 217A-000679, 217A-000680, 217A-000681, 217A-000682, 217A-000683, 217A-000684, 217A-000685, 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217A-000864, 217A-000865, 217A-000866, 217A-000867, 217A-000869, 217A-000870, 217A-000871, 217A-000872, 217A-000873, 217A-000874, 217A-000875, 217A-000876, 217A-000877, 217A-000878, 217A-000879, 217A-000880, 217A-000902, and 217A-000904.
• Recalling Firm/ Manufacturer: Del Mar Reynolds Medical, Ltd.; 1-2 Harforde Ct., Foxholes; Business Park; Hertford United Kingdom
• For Additional Information Contact: Spacelabs Healthcare ; 800-522-7025 Ext. 2
• Manufacturer 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.
• FDA Determined 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = DXN and Original Applicant = SPACELABS HEALTHCARE LTD.