Class 2 Device Recall Ambulatory Blood Pressure Monitor

• Date Initiated by Firm: April 20, 2020
• Create Date: June 25, 2020
• Recall Status: Terminated on June 13, 2023
• Recall Number: Z-2429-2020
• Recall Event ID: 85515
• 510(K)Number: K151520
• Product Classification: System, measurement, blood-pressure, non-invasive - Product Code DXN
• Product: Oscar 2, Model 250 System
• Code Information: Catalog Numbers (Serial Numbers): 99-0133-00 (SN:00101086, SN:00101159, SN:00101248, SN:00102173, SN:00107798, SN:00112277, SN:00113151, SN:00113262, SN:00113268, SN:00113279, SN:00113717, SN:00113838, SN:00114084, SN:00114513, SN:00115988, SN:00116238, SN:00116258, SN:00116331, SN:00116380, SN:00116384, SN:00116419, SN:00116423, SN:00116443, SN:00116445, SN:00116970, SN:00116974, SN:00116992, SN:00116993, SN:00117006, SN:00117017, SN:00117142, SN:00117160, SN:00117170, SN:00117926, SN:00117938, SN:00117941, SN:00117945, SN:00117952, SN:00117960, SN:00117968, SN:00118369, SN:00118370, SN:00118375, SN:00118382, SN:00118398, SN:00118403, SN:00118420, SN:00118428, SN:00118431, SN:00118541, SN:00118570, SN:00118698, SN:00118707, SN:00118728, SN:00118731, SN:00118741, SN:00118743, SN:00118914, SN:00118917, SN:00118919, SN:00118924, SN:00118926, SN:00118931, SN:00118932, SN:00118934, SN:00118940, SN:00121987, SN:00122088, SN:00122208, SN:00122209, SN:00122310, SN:00122350, SN:00122361, SN:00122365, SN:00122369, SN:00123475, SN:00123497, SN:00123503, SN:00124512, SN:00124516, SN:00124518, SN:00124530, SN:00124546, SN:00124585, SN:00124593, SN:00125141, SN:00125296, SN:00125302, SN:00125303, SN:00125305, SN:00125307, SN:00125308, SN:00125309, SN:00125310, SN:00125312, SN:00125313, SN:00125315, SN:00125317, SN:00125318, SN:00125319, SN:00125320, SN:00125321, SN:00125323, SN:00125325, SN:00125326, SN:00125330, SN:00125337, SN:00125339, SN:00125341, SN:00125342, SN:00125344, SN:00125345, SN:00125346, SN:00125348, SN:00125349, SN:00125350, SN:00125351, SN:00125353, SN:00125354, SN:00125356, SN:00125357, SN:00125358, SN:00125359, SN:00125360, SN:00125361, SN:00125362, SN:00125363, SN:00125365, SN:00125366, SN:00125367, SN:00125368, SN:00125369, SN:00125370, SN:00125371, SN:00125372, SN:00125373, SN:00125374, SN:00125375, SN:00125376, SN:00125377, SN:00125378, SN:00125379, SN:00125380, SN:00125381, SN:00125382, SN:00125383, SN:00125384, SN:00125385, SN:00125386, SN:00125387, SN:00125388, SN:00125389, SN:00125390, SN:00125397, SN:00125398, SN:00125399, SN:00125400, SN:00125402, SN:00125403, SN:00125405, SN:00125406, SN:00125407, SN:00125408, SN:00125409, SN:00125410, SN:00125411, SN:00125412, SN:00125413, SN:00125414, SN:00125415, SN:00125417, SN:00125418, SN:00125419, SN:00125420, SN:00125422, SN:00125423, SN:00125424, SN:00125425, SN:00125426, SN:00125427, SN:00125428, SN:00125429, SN:00125431, SN:00125432, SN:00125433, SN:00125435, SN:00125436, SN:00125439, SN:00125440, SN:00125442, SN:00125445, SN:00125447, SN:00125450, SN:00125451, SN:00125452, SN:00125455, SN:00125456, SN:00125458, SN:00125460, SN:00125461, SN:00125465, SN:00125466, SN:00125467, SN:00125468, SN:00125469, SN:00125470, SN:00125471, SN:00125472, SN:00125473, SN:00125474, SN:00125475, SN:00125476, SN:00125477, SN:00125478, SN:00125479, SN:00125480, SN:00125481, SN:00125482, SN:00125483, SN:00125484, SN:00125485, SN:00125486, SN:00125487, SN:00125488, SN:00125489, SN:00125490, SN:00125491, SN:00125492, SN:00125493, SN:00125494, SN:00125495, SN:00125496, SN:00125497, SN:00125499, SN:00125500, SN:00125501, SN:00125502, SN:00125503, SN:00125504, SN:00125505, SN:00125506, SN:00125507, SN:00125508, SN:00125509, SN:00125510, SN:00125511, SN:00125512, SN:00125514, SN:00125515, SN:00125517, SN:00125518, SN:00125519, SN:00125520, SN:00125523, SN:00125525, SN:00125528, SN:00125530, SN:00125531, SN:00125532, SN:00125534, SN:00125535, SN:00125536, SN:00125537, SN:00125538, SN:00125539, SN:00125540, SN:00125541, SN:00125542, SN:00125543, SN:00125544, SN:00125545, SN:00125546, SN:00125547, SN:00125548, SN:00125549, SN:00125550, SN:00125551, SN:00125552, SN:00125553, SN:00125554, SN:00125555, SN:00125556, SN:00125557, SN:00125558, SN:00125559, SN:00125560, SN:00125561, SN:00125715, SN:00125717, SN:00125718, SN:00125719, SN:00125720, SN:00125721, SN:00125723, SN:00125724, SN:00125725, SN:00125726, SN:00125727, SN:00125728, SN:00125729, SN:00125730, SN:00125731, SN:00125732, SN:00125733, SN:00125734, SN:00125735, SN:00125737, SN:00125738, SN:00125739, SN:00125740, SN:00125741, SN:00125742, SN:00125743, SN:00125744, SN:00125745, SN:00125746, SN:00125747, SN:00125748, SN:00125749, SN:00125750, SN:00125751, SN:00125753, SN:00125754, SN:00125755, SN:00125756, SN:00125757, SN:00125758, SN:00125759, SN:00125760, SN:00125761, SN:00125762, SN:00125763, SN:00125764, SN:00125765, SN:00125766, SN:00125767, SN:00125768, SN:00125769, SN:00125770, SN:00125771, SN:00125773, SN:00125774, SN:00125775, SN:00125776, SN:00125777, SN:00125778, SN:00125779, SN:00125780, SN:00125781, SN:00125782, SN:00125783, SN:00125784, SN:00125785, SN:00125786, SN:00125787, SN:00125788, SN:00125789, SN:00125790, SN:00125791, SN:00125792, SN:00125793, SN:00125794, SN:00125795, SN:00125796, SN:00125797, SN:00125798, SN:00125799, SN:00125800, SN:00125801, SN:00125802, SN:00125803, SN:00125804, SN:00125805, SN:00125806, SN:00125807, SN:00125808, SN:00125809, SN:00125810, SN:00125811, SN:00125812, SN:00125813, SN:00125814, SN:00125816, SN:00125817, SN:00125818, SN:00125819, SN:00125820, SN:00125821, SN:00125822, SN:00125878, SN:00125879, SN:00125880, SN:00125881, SN:00125882, SN:00125883, SN:00125884, SN:00125885, SN:00125886, SN:00125887, SN:00125890, SN:00125891, SN:00125892, SN:00125893, SN:00125894, SN:00125895, SN:00125897, SN:00125899, SN:00125901, SN:00125902, SN:00125903, SN:00125904, SN:00125905, SN:00125906, SN:00125907, SN:00125908, SN:00125909, SN:00125910, SN:00125911, SN:00125912, SN:00125913, SN:00125914, SN:00125915, SN:00125916, SN:00125917, SN:00125918, SN:00125919, SN:00125920, SN:00125921, SN:00125922, SN:00125923, SN:00125924, SN:00125925, SN:00125926, SN:00125927, SN:00125928, SN:00125929, SN:00125930, SN:00125931, SN:00125932, SN:00125933, SN:00125934, SN:00125935, SN:00125936, SN:00125937, SN:00126066, SN:00126067, SN:00126068, SN:00126069, SN:00126070, SN:00126071, SN:00126072, SN:00126073, SN:00126074, SN:00126075, SN:00126076, SN:00126077, SN:00126078, SN:00126079, SN:00126080, SN:00126081, SN:00126082, SN:00126083, SN:00126084, SN:00126085, SN:00126086, SN:00126087, SN:00126088, SN:00126089, SN:00126090, SN:00126091, SN:00126092, SN:00126094, SN:00126095, SN:00126096, SN:00126097, SN:00126098, SN:00126099, SN:00126100, SN:00126101, SN:00126102, SN:00126103, SN:00126104, SN:00126105, SN:00126106, SN:00126107, SN:00126108, SN:00126109, SN:00126110, SN:00126111, SN:00126112, SN:00126113, SN:00126114, SN:00126115, SN:00126116, SN:00126117, SN:00126118, SN:00126119, SN:00126120, SN:00126121, SN:00126122, SN:00126123, SN:00126124, SN:00126125, SN:00126127, SN:00126128, SN:00126129, SN:00126130, SN:00126131, SN:00126132, SN:00126133, SN:00126134, SN:00126135, SN:00126137, SN:00126138, SN:00126139, SN:00126140, SN:00126141, SN:00126142, SN:00126143, SN:00126144, SN:00126145, SN:00126146, SN:00126147, SN:00126148, SN:00126149, SN:00126150, SN:00126151, SN:00126152, SN:00126153, SN:00126154, SN:00126155, SN:00126156, SN:00126157, SN:00126158, SN:00126159, SN:00126160, SN:00126161, SN:00126162, SN:00126163, SN:00126164, SN:00126165, SN:00126166, SN:00126167, SN:00126168, SN:00126169, SN:00126170, SN:00126171, SN:00126172, SN:00126174, SN:00126175, SN:00126177, SN:00126178, SN:00126179, SN:00126180, SN:00126181, SN:00126182, SN:00126183, SN:00126184, SN:00126185, SN:00126186, SN:00126187, SN:00126188, SN:00126189, SN:00126190, SN:00126191, SN:00126192, SN:00126193, SN:00126194, SN:00126195, SN:00126196, SN:00126197, SN:00126198, SN:00126199, SN:00126200, SN:00126201, SN:00126202, SN:00126203, SN:00126204, SN:00126205, SN:00126206, SN:00126207, SN:00126208, SN:00126209, SN:00126210, SN:00126211, SN:00126212, SN:00126213, SN:00126214, SN:00126215, SN:00126449, SN:00126450, SN:00126451, SN:00126452, SN:00126453, SN:00126454, SN:00126455, SN:00126456, SN:00126457, SN:00126458, SN:00126459, SN:00126460, SN:00126461, SN:00126462, SN:00126463, SN:00126464, SN:00126465, SN:00126466, SN:00126467, SN:00126468, SN:00126469, SN:00126470, SN:00126471, SN:00126472, SN:00126473, SN:00126474, SN:00126475, SN:00126476, SN:00126477, SN:00126478, SN:00126479, SN:00126480, SN:00126481, SN:00126482, SN:00126483, SN:00126484, SN:00126485, SN:00126486, SN:00126487, SN:00126488, SN:00126489, SN:00126490, SN:00126491, SN:00126492, SN:00126493, SN:00126494, SN:00126495, SN:00126496, SN:00126497, SN:00126498, SN:00126499, SN:00126500, SN:00126501, SN:00126502, SN:00126503, SN:00126504, SN:00126505, SN:00126506, SN:00126507, SN:00126508, SN:00126509, SN:00126510, SN:00126511, SN:00126512, SN:00126513, SN:00126514, SN:00126517, SN:00126518, SN:00126519, SN:00126520, SN:00126521, SN:00126522, SN:00126523, SN:00126524, SN:00126525, SN:00126526, SN:00126527, SN:00126528, SN:00126535, SN:00126536, SN:00126537, SN:00126538, SN:00126539, SN:00126540, SN:00126541, SN:00126542, SN:00126543, SN:00126544, SN:00126545, SN:00126546, SN:00126547, SN:00126548, SN:00126549, SN:00126550, SN:00126551, SN:00126552, SN:00126553, SN:00126554, SN:00126594, SN:00126595, SN:00126596, SN:00126598, SN:00126599, SN:00126600, SN:00126601, SN:00126602, SN:00126603, SN:00126604, SN:00126605, SN:00126606, SN:00126607, SN:00126608, SN:00126611, SN:00126612, SN:00126613, SN:00126614, SN:00126617, SN:00126618, SN:00126619, SN:00126620, SN:00126621, SN:00126622, SN:00126623, SN:00126624, SN:00126625, SN:00126626, SN:00126627, SN:00126759, SN:00126760, SN:00126761, SN:00126762, SN:00126763, SN:00126764, SN:00126766, SN:00126767, SN:00126768, SN:00126769, SN:00126770, SN:00126771, SN:00126772, SN:00126773, SN:00126774, SN:00126775, SN:00126776, SN:00126777, SN:00126778, SN:00126799, SN:00126800, SN:00126801, SN:00126802, SN:00126803, SN:00126804, SN:00126805, SN:00126806, SN:00126807, SN:00126809, SN:00126810, SN:00126811, SN:00126812, SN:00126813, SN:00126814, SN:00126815, SN:00126816, SN:00126817, SN:00126818, SN:00126819, SN:00126820, SN:00126821, SN:00126822, SN:00126823, SN:00126825, SN:00126826, SN:00126827, SN:00126828, SN:00126829, SN:00126830, SN:00126831, SN:00126832, SN:00126833, SN:00126834, SN:00126835, SN:00126836, SN:00126837, SN:00126838, SN:00126859, SN:00126860, SN:00126861, SN:00126862, SN:00126863, SN:00126864, SN:00126865, SN:00126866, SN:00126867, SN:00126868, SN:00126875, SN:00126876, SN:00126877, SN:00126878, SN:00127152, SN:00127616, SN:00127617, SN:00127619, SN:00127620, SN:00127644, SN:00127645, SN:00127646, SN:00127647, SN:00127651, SN:00127652, SN:00127654, SN:00127655, SN:00127658, SN:00127661, SN:00127683, SN:00127688, SN:00127689, SN:00127690, SN:00127695, SN:00127697, SN:00127700, SN:00127702); 99-0133-01 (SN:00115777, SN:00126374, SN:00127147, SN:00127148, SN:00127149, SN:00127150, SN:00127151, SN:00127153); 99-0133-02 (SN:00121249, SN:00122486, SN:00126376, SN:00127775, SN:00127776); 99-0133-03 (SN:00114191, SN:00116184, SN:00119788, SN:00127721, SN:00127722), 99-0133-10 (SN:00116330, SN:00118366, SN:00118371, SN:00118390, SN:00118422, SN:00118555, SN:00118565, SN:00118721, SN:00118928, SN:00124517, SN:00124928, SN:00125343, SN:00125347, SN:00125352, SN:00125355, SN:00125404, SN:00125416, SN:00125421, SN:00125430, SN:00125434, SN:00125438, SN:00125441, SN:00125443, SN:00125444, SN:00125446, SN:00125448, SN:00125449, SN:00125453, SN:00125454, SN:00125457, SN:00125462, SN:00125498, SN:00125521, SN:00125522, SN:00125524, SN:00125526, SN:00125527, SN:00125529, SN:00125533, SN:00125716, SN:00125736, SN:00125752, SN:00125772, SN:00125888, SN:00125889, SN:00125896, SN:00125898, SN:00125900, SN:00126173, SN:00126597, SN:00126615, SN:00127696); 99-0133-22 (SN:00112837, SN:00122038, SN:00122044, SN:00127710, SN:00127711, SN:00127712, SN:00127714); 99-0133-40 (SN:00113429, SN:00113459, SN:00113466, SN:00113480, SN:00117321, SN:00117327, SN:00121430, SN:00121435, SN:00121442, SN:00121446, SN:00121447, SN:00121448, SN:00121449, SN:00121466, SN:00121468, SN:00121470, SN:00121474, SN:00121481, SN:00121484, SN:00121485, SN:00121486, SN:00121488, SN:00121489, SN:00121490, SN:00121491, SN:00121492, SN:00121494, SN:00127146, SN:00127161, SN:00127162, SN:00127163, SN:00127164, SN:00127165, SN:00127166, SN:00127167, SN:00127169, SN:00127170, SN:00127171, SN:00127172, SN:00127173, SN:00127174, SN:00127175, SN:00127176, SN:00127177, SN:00127179, SN:00127180, SN:00127182, SN:00127183, SN:00127184, SN:00127185, SN:00127187, SN:00127189, SN:00127190, SN:00127192, SN:00127193, SN:00127194, SN:00127195, SN:00127196, SN:00127198, SN:00127199, SN:00127200, SN:00127202, SN:00127205, SN:00127207, SN:00127208, SN:00127209, SN:00127211, SN:00127212, SN:00127213, SN:00127214, SN:00127215, SN:00127216, SN:00127217, SN:00127218, SN:00127219, SN:00127220, SN:00127221, SN:00127222, SN:00127223, SN:00127229, SN:00127230, SN:00127231, SN:00127232, SN:00127233, SN:00127234, SN:00127235, SN:00127236, SN:00127237, SN:00127238, SN:00127239, SN:00127240, SN:00127241, SN:00127242, SN:00127243, SN:00127244, SN:00127245, SN:00127246, SN:00127247, SN:00127248, SN:00127249, SN:00127250, SN:00127251, SN:00127252, SN:00127253, SN:00127254, SN:00127255, SN:00127256, SN:00127257, SN:00127258, SN:00127260, SN:00127261, SN:00127262, SN:00127263, SN:00127264, SN:00127266, SN:00127267, SN:00127268, SN:00127269, SN:00127270, SN:00127271, SN:00127272, SN:00127273, SN:00127274, SN:00127275, SN:00127276, SN:00127277, SN:00127278, SN:00127279, SN:00127280, SN:00127281, SN:00127282, SN:00127283, SN:00127284, SN:00127285, SN:00127286, SN:00127287, SN:00127288, SN:00127289, SN:00127290, SN:00127291, SN:00127292, SN:00127293, SN:00127294, SN:00127295, SN:00127296, SN:00127297, SN:00127298, SN:00127299, SN:00127300, SN:00127701).
• Recalling Firm/ Manufacturer: Suntech Medical, Inc.; 507 Airport Blvd Ste 117; Morrisville NC 27560-8200
• For Additional Information Contact: Charles Setzer; 919-654-2332
• Manufacturer Reason for Recall: The device display, when activated, can show an incorrect decimal point when the blood pressure reading is a three-digit number and the unit of measure is set for mmHg.
• FDA Determined Cause: Process change control
• Action: Suntech Medical Instruments, Inc. notified customers on about [DATE] via "URGENT: MEDICAL DEVICE RECALL" letter. Customers were informed that the device display, when activated, can show an incorrect decimal point when the blood pressure reading is a three-digit number and the unit of measure is set for mmHg. Suntech Medical is instructing physicians and nurses that they can still use the device and are to ignore the readings on the device display and to continue to focus on the Accuwin Pro data for diagnosis. Best practice is to disable the device display during unit configuration and to instruct the patient to ignore any data that may be visible on the display. If these steps are followed, Suntech states the device can continue to be used. The correction will include 2 options: 1. To download the service tool at https://www.suntechmed.com/oscar2-display-update-request; or 2. Customers should contact SunTech to confirm the configuration has been corrected at recallcoordinator@suntechmed.com and provide the contact person, company name, and serial numbers of corrected devices. Additionally, customers were requested to complete and return the response form via email to recallcoordinator@suntechmed.com, or they can be sent by mail to: Recall Coordinator, SunTech Medical, Inc., 507 Airport Blvd, suite 117, Morrisville, NC 27560-8200. Questions can be addressed to SunTech Medical at Email: recallcoordinator@suntechmed.com, Phone: +1-800-421-8626 or 919-654-6128
• Quantity in Commerce: 1,037 units
• Distribution: Nationwide distribution to CA, CT, FL, IL, LA, MD, NC, NY, OH, PA, PR, SC, TN, TX, UT. Worldwide distribution to Australia, Austria, Belgium, Bermuda, Brazil, Canada, Croatia, Czech Republic, Dominican Republic, Estonia, France, India, Ireland, Latvia, Lebanon, Morocco, Pakistan, Peru, Poland, Saudi Arabia, Singapore, South Africa, Spain, Taiwan, United Kingdom, Vietnam.
• 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