Z-0520-2012

Lifescreen Apnea is Lifescreen ECG Screening System, Version 3.31. Lifescreen Apnea is indicated for...

Name: Z-0520-2012 Lifescreen Apnea is Lifescreen ECG Screening System, Version 3.31. Lifescreen Apnea is indicated for...
Creator: Del Mar Reynolds Medical, Ltd.
Published: 2011-11-11
License: https://open.fda.gov/license/

GE Healthcare / initiated 2011-11-11 / Terminated / root cause: software

FDA source

Del Mar Reynolds Medical, Ltd. began a recall of Lifescreen Apnea is Lifescreen ECG Screening System, Version 3.31. Lifescreen Apnea is indicated for screening adults for the probability that they suffer from... on 2011-11-11. The reason FDA records is "When Lifescreen is left open and a new recording is loaded from Sentinel Cardiology Information Management System, customers can get corruption in the data or a wrong ECG after the first 32 hours. Both recordings have...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0520-2012
Status: Terminated
Initiated: 2011-11-11
Posted: 2012-01-11
Terminated: 2012-06-05
Recalling firm: GE Healthcare
Product: Lifescreen Apnea is Lifescreen ECG Screening System, Version 3.31. Lifescreen Apnea is indicated for screening adults for the probability that they suffer from obstructive sleep apnea, mixed apnea or hypopnea, in order to evaluate the necessity for a polysomonographic examination. The ECG recording may be obtained at any location specified by a physician including home, hospital or clinic. Subjects screened for sleep apnea should have periods of sleep of at least 4 hours duration during which the ECG is predominantly sinus rhythm in nature.
Product code: MNR Ventilatory Effort Recorder
Reason for recall: When Lifescreen is left open and a new recording is loaded from Sentinel Cardiology Information Management System, customers can get corruption in the data or a wrong ECG after the first 32 hours. Both recordings have to be longer than 32 hours for this to happen.
Root cause tag: software
FDA root cause: Software design
Action: Spacelabs Healthcare sent an "URGENT-MEDICAL DEVICE CORRECTION" letter dated November 11, 2011 to all affected customers. The letter described the product, problem, and actions to be taken by the customers. Customers are advised to close Lifescreen every time before loading another recording from the Sentinel database. Spacelabs is in the process of upgrading software and will contact customers to arrange for an update to affected systems. If you have any questions about this corrective action program, please contact Spacelabs Healthcare at 1-800-522-7025 and select 2 for Technical Support.
Quantity in commerce: total 523 units and 171 kits (34 units and 7 kits in US; 489 units and 164 kits outside US)
Distribution: Worldwide Distribution-USA (nationwide) including the states of AR, CA, CO, CT, FL, GA, KY, LA, MA, MD, MI, MN, NC, NY, OH, TN, TX, UT, WV, and PUERTO RICO and the countries of AUSTRIA, BELGIUM, CHILE, CHINA, COLOMBIA, COSTA RICA, DENMARK, FINLAND, FRANCE, GERMANY, GREECE, HONDURAS, HONG KONG, HUNGARY, INDIA, ISRAEL, ITALY, KUWAIT, MALTA, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, POLAND, PORTUGAL, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, Slovakia, SPAIN, SWEDEN, SWITZERLAND, TURKEY, UNITED ARAB EMIRATES, and UNITED KINGDOM
Product codes and lots: There is no Serial Numbers for 169 Kits. Serial Numbers for 519 units: 12038, 32288, 32300, 32302, 32327, 32329, 32330, 32389, 32410, 32411, 32415, 32417, 32418, 32470, 32471, 32472, 32473, 32474, 32475, 32476, 32478, 32479, 32480, 32481, 32482, 32483, 32484, 32485, 32486, 32487, 32488, 32532, 32546, 32547, 32548, 32549, 32550, 32551, 32552, 32553, 32554, 32557, 32558, 32561, 32567, 32568, 32569, 32570, 32648, 32649, 32650, 32651, 32652, 32653, 32655, 32656, 32657, 32658, 32659, 32676, 32677, 32678, 32679, 32680, 32681, 32682, 32683, 32684, 32686, 32687, 32712, 32713, 32714, 32715, 32716, 32717, 32718, 32719, 32720, 32721, 32722, 32723, 32726, 32742, 32759, 32790, 32791, 32797, 32798, 32799, 32800, 32801, 32802, 32803, 32804, 32805, 32806, 32814, 32821, 32822, 32823, 32824, 32860, 32861, 32862, 32863, 32864, 32865, 32866, 32867, 32868, 32869, 32870, 32871, 32872, 32873, 32877, 32878, 32880, 32881, 32944, 32945, 32946, 32947, 32948, 32949, 32950, 32951, 32952, 32954, 32955, 32956, 32957, 32958, 32959, 32960, 32961, 32963, 32977, 32979, 32980, 32982, 32983, 32984, 32986, 32987, 32989, 32990, 32991, 32992, 32993, 32994, 32995, 33015, 33017, 33058, 33095, 33096, 33097, 33098, 33099, 33100, 33101, 33102, 33103, 33104, 33105, 33106, 33107, 33108, 33113, 33114, 33115, 33116, 33117, 33118, 33119, 33120, 33121, 33122, 33123, 33124, 33132, 33135, 33158, 33159, 33160, 33161, 33162, 33164, 33165, 33166, 33167, 33184, 33185, 33186, 33188, 33189, 33190, 33200, 33201, 33213, 33219, 33221, 33240, 33241, 33242, 33243, 33244, 33245, 33254, 33255, 33257, 33258, 33259, 33260, 33261, 33262, 33263, 33264, 33265, 33267, 33268, 33269, 33270, 33322, 33323, 33324, 33326, 33327, 33328, 33329, 33330, 33336, 33337, 33338, 33339, 33343, 33347, 33348, 33352, 33355, 33386, 33387, 33388, 33391, 33392, 33393, 33394, 33396, 9310, 9520, 9885, 9933, 9934, IMP-002054, IMP-005010, IMP-005011, IMP-005013, IMP-005025, IMP-005027, IMP-005028, IMP-005029, IMP-005030, IMP-005031, IMP-005035, IMP-005036, IMP-005038, IMP-005039, IMP-005042, IMP-005043, IMP-005045, IMP-005046, IMP-005048, IMP-005049, IMP-005050, IMP-005062, IMP-005063, IMP-005065, IMP-005066, IMP-005068, IMP-005073, IMP-005077, IMP-005078, IMP-005087, IMP-005090, IMP-005091, IMP-005092, IMP-005094, IMP-005102, IMP-005108, IMP-005110, IMP-005111, IMP-005115, IMP-005141, IMP-005147, IMP-005151, IMP-005152, IMP-005160, IMP-005162, IMP-005165, IMP-005176, IMP-005218, IMP-005219, IMP-005237, IMP-005238, IMP-005253, IMP-005254, IMP-005258, LIFE-025878, LIFE-027365, LIFE-027527, LIFE-027528, LIFE-027866, LIFE-028314, LIFE-029149, LIFE-029150, LIFE-029718, LIFE-029719, LIFE-032784, LIFE-033181, LIFE-033791, PATH-000100, PATH-000101, PATH-000102, PATH-000103, PATH-000104, PATH-000105, PATH-000106, PATH-000107, PATH-006004, PATH-006005, PATH-006006, PATH-006007, PATH-006018, PATH-006019, PATH-006020, PATH-006039, PATH-006040, PATH-006041, PATH-006042, PATH-006043, PATH-006044, PATH-006045, PATH-006068, PATH-006069, PATH-006070, PATH-006071, PATH-006072, PATH-006073, PATH-006074, PATH-006075, PATH-006077, PATH-006099, PATH-006101, PATH-006102, PATH-006103, PATH-006104, PATH-006105, PATH-006106, PATH-006108, PATH-006109, PATH-006110, PATH-006112, PATH-006113, PATH-006114, PATH-006115, PATH-006120, PATH-006132, PATH-006158, PATH-006159, PATH-006160, PATH-006161, PATH-006162, PATH-006163, PATH-006164, PATH-006165, PATH-006166, PATH-006175, PATH-006182, PATH-006183, PATH-006184, PATH-006186, PATH-006188, PATH-006190, PATH-006237, PATH-006238, PATH-006239, PATH-006250, PATH-006251, PATH-006252, PATH-006253, PATH-006254, PATH-006255, PATH-006256, PATH-006258, PATH-006259, PATH-006299, PATH-006300, PATH-006301, PATH-006302, PATH-006306, PATH-006309, PATH-006314, PATH-006315, PATH-006316, PATH-006317, PATH-006318, PATH-006319, PATH-006320, PATH-006321, PATH-006322, PATH-006323, PATH-006324, PATH-006325, PATH-006326, PATH-006327, PATH-006328, PATH-006329, PATH-006332, PATH-006333, PATH-006344, PATH-006350, PATH-006351, PATH-006353, PATH-006382, PATH-006407, PATH-006409, PATH-006410, PATH-006447, PATH-006448, PATH-006451, PATH-006452, PATH-006471, PATH-006485, PATH-006486, PATH-006487, PATH-006488, PATH-006489, PATH-006490, PATH-006502, PATH-006505, PATH-006506, PATH-006522, PATH-006523, PATH-006524, PATH-006525, PATH-006526, PATH-006527, PATH-006528, PATH-006531, PATH-006533, PATH-006537, PATH-006538, PATH-006542, PATH-006543, PATH-006544, PATH-006545, PATH-006572, PATH-006573, PATH-006574, PATH-006602, PATH-006603, PATH-006604, PATH-006605, PATH-006606, PATH-006607, PATH-006608, PATH-006609, PATH-006610, PATH-006611, PATH-006612, PATH-006613, PATH-006614, PATH-006615, PATH-006630, PATH-006631, PATH-006632, PATH-006638, PATH-006650, PATH-006651, PATH-006652, PATH-006662, PATH-006663, PATH-006664, PATH-006665, PATH-006666, PATH-006667, PATH-006698, PATH-006712, PATH-006713, PATH-006714, PATH-006715, PATH-006716, PATH-006717, PATH-006735, PATH-006736, PATH-006738, PATH-006739, PATH-006740, PATH-006741, PATH-006742, PATH-006743, PATH-006744, PATH-006774, PATH-006830, PATH-006831, PATH-006853, PATH-006858, PATH-006859, PATH-006860, PATH-006861, PATH-006862, PATH-006872, PATH-006873, PATH-006874, PATH-006877, PATH-006878, PATH-006984. 4 additional serial numbers were added 6/5/12 - PATH-006332, PATH-006333, PATH-006350, and PATH-006351.

Product code MNR

K042745Class IILifescreen ApneaDel Mar Reynolds Medical, Inc. / cleared 2005-01-19

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)