Xhibit Central Station, Model 96102. Intended use is to provide clinicians with central monitoring of adult, pediatric and neonatal patient data of patients connected to networked Spacelabs Healthcare patient monitors and telemetry transmitters.
- Company
- Spacelabs Healthcare, Inc.
- Recall Initiated
- October 18, 2016
- Posted
- November 2, 2016
- Terminated
- April 3, 2017
- Recall Number
- Z-0332-2017
- Quantity
- 348 units (292 units in the US and 56 units outside the US)
- Firm Location
- Snoqualmie, WA
Reason for Recall
The firm received reports of telemetry SpO2 numerics dropping off the Xhibit Central display. Desaturation, high, and low limit alarms work normally.
Distribution
Worldwide Distribution -- USA, to AL, CA, CT, FL, GA, IA, ID, IL, IN, KY, MI, MN, MS, NC, NE, NJ, NY, OH, OK, PA, RI, SC, SD, TX, VA, WA, WY, and Puerto Rico; and, to the countries of AUSTRALIA, CANADA, CHILE, CZECH REPUBLIC, FRANCE, MEXICO, NETHERLANDS, PANAMA, SAUDI ARABIA, SWITZERLAND, TAIWAN, and UNITED KINGDOM.
Lot / Code Info
Software version 1.1.5, Affected Serial Numbers in the US ************************************* ADDITIONAL FIVE UNITS ADDED: SLA0216F01796; SLA0216F01808; SLA1215F01638; SLA1215F01645; SLA1215F01652; SLA0114F00445, SLA0114F00446, SLA0114F00447, SLA0115F00917, SLA0115F00918, SLA0115F00919, SLA0115F00921, SLA0115F00923, SLA0115F00924, SLA0115F00927, SLA0115F00928, SLA0115F00934, SLA0115F00955, SLA0115F00961, SLA0115F00968, SLA0115F00969, SLA0115F00972, SLA0115F00976, SLA0116F01718, SLA0116F01720, SLA0116F01722, SLA0214F00489, SLA0216F01807, SLA0216F01809, SLA0216F01813, SLA0216F01821, SLA0216F01824, SLA0216F01837, SLA0216F01840, SLA0216F01844, SLA0314F00534, SLA0314F00535, SLA0314F00540, SLA0314F00543, SLA0314F00547, SLA0314F00548, SLA0314F00549, SLA0314F00552, SLA0314F00561, SLA0314F00567, SLA0414F00568, SLA0414F00585, SLA0416F01850, SLA0416F01853, SLA0416F01857, SLA0416F01860, SLA0416F01875, SLA0416F01876, SLA0416F01883, SLA0416F01885, SLA0416F01889, SLA0416F01895, SLA0416F01923, SLA0516F01969, SLA0516F01970, SLA0516F01972, SLA0516F01974, SLA0516F01975, SLA0516F01976, SLA0516F01977, SLA0516F01978, SLA0516F01981, SLA0516F01982, SLA0516F01985, SLA0516F01986, SLA0516F01987, SLA0516F01992, SLA0516F02002, SLA0516F02005, SLA0614F00631, SLA0614F00654, SLA0615F01188, SLA0615F01194, SLA0615F01197, SLA0615F01198, SLA0615F01199, SLA0615F01213, SLA0615F01237, SLA0615F01238, SLA0615F01239, SLA0615F01240, SLA0615F01244, SLA0615F01248, SLA0615F01261, SLA0714F00678, SLA0714F00688, SLA0714F00694, SLA0714F00702, SLA0714F00703, SLA0715F01274, SLA0715F01310, SLA0715F01314, SLA0715F01325, SLA0715F01331, SLA0715F01334, SLA0715F01346, SLA0715F01347, SLA0716F02009, SLA0716F02011, SLA0716F02013, SLA0716F02015, SLA0716F02016, SLA0716F02017, SLA0716F02020, SLA0716F02021, SLA0716F02022, SLA0716F02028, SLA0716F02034, SLA0716F02042, SLA0716F02043, SLA0716F02044, SLA0716F02045, SLA0814F00713, SLA0815F01371, SLA0815F01372, SLA0815F01373, SLA0815F01374, SLA0815F01375, SLA0815F01376, SLA0815F01379, SLA0815F01380, SLA0815F01381, SLA0815F01382, SLA0815F01383, SLA0815F01384, SLA0815F01386, SLA0815F01387, SLA0815F01388, SLA0815F01390, SLA0815F01391, SLA0815F01395, SLA0815F01397, SLA0815F01400, SLA0815F01402, SLA0815F01403, SLA0815F01404, SLA0815F01405, SLA0815F01406, SLA0815F01407, SLA0815F01408, SLA0815F01409, SLA0815F01412, SLA0815F01415, SLA0815F01418, SLA0815F01419, SLA0815F01424, SLA0816F02048, SLA0816F02050, SLA0816F02051, SLA0816F02052, SLA0816F02053, SLA0816F02054, SLA0816F02055, SLA0816F02056, SLA0816F02057, SLA0816F02058, SLA0816F02059, SLA0816F02060, SLA0816F02061, SLA0816F02062, SLA0816F02063, SLA0816F02065, SLA0816F02066, SLA0816F02067, SLA0816F02074, SLA0816F02075, SLA0816F02076, SLA0816F02077, SLA0816F02078, SLA0816F02081, SLA0816F02082, SLA0816F02083, SLA0816F02085, SLA0816F02087, SLA0816F02089, SLA0816F02091, SLA0816F02092, SLA0816F02093, SLA0816F02094, SLA0816F02095, SLA0816F02096, SLA0816F02097, SLA0816F02098, SLA0816F02099, SLA0816F02100, SLA0816F02101, SLA0816F02102, SLA0816F02103, SLA0816F02104, SLA0816F02105, SLA0816F02106, SLA0816F02107, SLA0915F01439, SLA0915F01442, SLA0915F01447, SLA0915F01451, SLA0915F01452, SLA0915F01457, SLA0915F01459, SLA0915F01462, SLA0915F01468, SLA0915F01474, SLA0915F01493, SLA0915F01496, SLA0915F01497, SLA0915F01498, SLA0915F01499, SLA0915F01501, SLA0915F01503, SLA0915F01506, SLA0915F01507, SLA0915F01508, SLA0915F01510, SLA0915F01511, SLA0915F01512, SLA0915F01513, SLA0915F01514, SLA0916F02108, SLA0916F02110, SLA0916F02111, SLA0916F02112, SLA0916F02114, SLA0916F02115, SLA0916F02117, SLA0916F02121, SLA0916F02122, SLA0916F02123, SLA0916F02126, SLA0916F02127, SLA0916F02130, SLA0916F02131, SLA0916F02132, SLA0916F02133, SLA0916F02134, SLA0916F02136, SLA0916F02137, SLA0916F02138, SLA0916F02139, SLA0916F02141, SLA0916F02142, SLA0916F02143, SLA0916F02145, SLA0916F02146, SLA0916F02147, SLA0916F02148, SLA0916F02149, SLA0916F02150, SLA0916F02153, SLA0916F02154, SLA0916F02155, SLA0916F02156, SLA0916F02158, SLA0916F02159, SLA0916F02160, SLA0916F02162, SLA0916F02163, SLA0916F02165, SLA0916F02166, SLA1015F01525, SLA1015F01528, SLA1015F01530, SLA1015F01540, SLA1015F01551, SLA1015F01560, SLA1114F00795, SLA1114F00820, SLA1115F01578, SLA1115F01579, SLA1115F01582, SLA1115F01584, SLA1115F01593, SLA1115F01594, SLA1115F01595, SLA1115F01596, SLA1115F01597, SLA1115F01599, SLA1115F01602, SLA1115F01603, SLA1115F01608, SLA1115F01609, SLA1214F00858, SLA1214F00871, SLA1214F00876, SLA1214F00881, SLA1214F00885, SLA1214F00886, and SLA1215F01632. ***********Affected Serial Numbers OUTSIDE the US ************************** SLA0114F00430, SLA0114F00437, SLA0114F00438, SLA0114F00439, SLA0114F00440, SLA0114F00443, SLA0115F00975, SLA0116F01724, SLA0314F00528, SLA0314F00541, SLA0414F00596, SLA0416F01872, SLA0416F01877, SLA0416F01880, SLA0612F00235, SLA0715F01270, SLA0715F01271, SLA0715F01273, SLA0715F01283, SLA0715F01335, SLA0716F02023, SLA0716F02025, SLA0716F02029, SLA0716F02031, SLA0716F02035, SLA0716F02036, SLA0716F02037, SLA0716F02040, SLA0716F02041, SLA0716F02047, SLA0815F01431, SLA0816F02049, SLA0816F02064, SLA0816F02069, SLA0816F02070, SLA0816F02071, SLA0816F02072, SLA0816F02073, SLA0816F02079, SLA0816F02080, SLA0816F02084, SLA0816F02086, SLA0916F02109, SLA0916F02118, SLA0916F02119, SLA0916F02120, SLA0916F02128, SLA0916F02129, SLA0916F02140, SLA0916F02161, SLA1014F00776, SLA1113F00348, SLA1113F00368, SLA1115F01604, SLA1115F01605, and SLA1213F00389.
Root Cause
Software design
Action Taken
The firm sent the Urgent - Medical Device Correction letter, dated 18 October 2016, via priority service, return receipt requested, to all U.S. customers on 10/18/16. The firm will e-mail a customer letter (translated as necessary) to all international subsidiaries and distributors of record on October 25, 2016. Xhibit Central Stations used without Xhibit Telemetry Receivers, are not affected. Customers were asked to circulate the letter to all person affected and place a copy with the appropriate monitor user manual until corrections have been implemented. Spacelabs Healthcare will contact affected consignees to schedule a convenient time for Spacelabs to update the affected Xhibit Central Station(s) with a new software version 1.1.6 at no cost. Customers with questions can call Technical Support at 1-800-522-7025 and select 2.