Z-0332-2017Class II

Xhibit Central Station, Model 96102. Intended use is to provide clinicians with central monitoring of adult...

Name: Z-0332-2017 Xhibit Central Station, Model 96102. Intended use is to provide clinicians with central monitoring of adult...
Creator: Spacelabs Healthcare Inc
Published: 2016-10-18
License: https://open.fda.gov/license/

GE Healthcare / initiated 2016-10-18 / Terminated / root cause: software

FDA source

Spacelabs Healthcare Inc began a recall of Xhibit Central Station, Model 96102. Intended use is to provide clinicians with central monitoring of adult, pediatric and neonatal patient data of patients... on 2016-10-18. FDA classified it as Class II and gives the reason as "The firm received reports of telemetry SpO2 numerics dropping off the Xhibit Central display. Desaturation, high, and low limit alarms work normally". 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-0332-2017
Classification: Class II
Status: Terminated
Initiated: 2016-10-18
Posted: 2016-11-02
Terminated: 2017-04-03
Recalling firm: GE Healthcare
Product: 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.
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
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.
Root cause tag: software
FDA root cause: Software design
Action: 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.
Quantity in commerce: 348 units (292 units in the US and 56 units outside the US)
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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0332-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0332-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-09	2016-11-02

Product code MHX

K122146Class IIXhibit Central Station, Model 96102Spacelabs Healthcare / cleared 2013-04-22

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)