Z-0188-2014Class II

Spacelabs Healthcare elance Vital Signs Monitor, Model 93300, with Option S. It is a patient monitor with...

Name: Z-0188-2014 Spacelabs Healthcare elance Vital Signs Monitor, Model 93300, with Option S. It is a patient monitor with...
Creator: Spacelabs Healthcare, Llc
Published: 2013-10-17
License: https://open.fda.gov/license/

GE Healthcare / initiated 2013-10-17 / Terminated / root cause: manufacturing process

FDA source

Spacelabs Healthcare, Llc began a recall of Spacelabs Healthcare elance Vital Signs Monitor, Model 93300, with Option S. It is a patient monitor with arrhythmia detection or alarms on 2013-10-17. FDA classified it as Class II and gives the reason as "Spacelabs Healthcare elance Vital Signs Monitor with Option S, model 93330, is recalled because the monitor will not permit connection of any of the Spacelabs TruLink line of SpO2 sensors". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0188-2014
Classification: Class II
Status: Terminated
Initiated: 2013-10-17
Posted: 2013-11-08
Terminated: 2014-02-25
Recalling firm: GE Healthcare
Product: Spacelabs Healthcare elance Vital Signs Monitor, Model 93300, with Option S. It is a patient monitor with arrhythmia detection or alarms.
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Reason for recall: Spacelabs Healthcare elance Vital Signs Monitor with Option S, model 93330, is recalled because the monitor will not permit connection of any of the Spacelabs TruLink line of SpO2 sensors.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Spacelabs Healthcare sent the "URGENT -MEDICAL DEVICE CORRECTION Spacelabs Healthcare elance Vital Signs Monitor with Option S" letter, dated 01 November 2013, to the US consignee on November 1, 2013. Spacelabs Healthcare will send the customer letter (translated as necessary) to all international subsidiaries and distributors of record via email on November 6, 2013. USERS ARE ADVISED THAT: -They may not be able to monitor their patient's oxygen saturation because the monitor will not allow the TruLink SpO2 sensor to be connected. The clinician will be required to find an alternate method to monitor oxygen saturation. -They will be contacted at the earliest possible date to schedule a convenient time and Spacelabs will correct all of your facility's affected monitors at no cost. Customer in the US can call Spacelabs Healthcare, Inc. of Snoqualmie, Washington at 800-522-7025. If you have any questions about this corrective action program, please contact Spacelabs Healthcare at +86 512 87178304 for Technical Support.
Quantity in commerce: 89 units total (1 in US and 88 International)
Distribution: Worldwide Distribution-Distributed in Puerto Rico and the countries of France, Indonesia, Korea, Nicaragua, Philippines, and Taiwan.
Product codes and lots: SERIAL NUMBER IN THE US: 3300-203410 SERIAL NUMBERS INTERNATIONAL: 3300-203361, 3300-203362, 3300-203363, 3300-203364, 3300-203386, 3300-203387, 3300-203388, 3300-203389, 3300-203390, 3300-203391, 3300-203392, 3300-203393, 3300-203394, 3300-203395, 3300-203396, 3300-203397, 3300-203398, 3300-203399, 3300-203400, 3300-203401, 3300-203402, 3300-203403, 3300-203404, 3300-203405, 3300-203406, 3300-203407, 3300-203408, 3300-203409, 3300-203410, 3300-203443, 3300-203444, 3300-203445, 3300-203446, 3300-203447, 3300-203448, 3300-203449, 3300-203450, 3300-203451, 3300-203452, 3300-203453, 3300-203454, 3300-203455, 3300-203456, 3300-203457, 3300-203458, 3300-203459, 3300-203460, 3300-203461, 3300-203462, 3300-203463, 3300-203464, 3300-203465, 3300-203466, 3300-203467, 3300-203468, 3300-203469, 3300-203470, 3300-203471, 3300-203472, 3300-203473, 3300-203474, 3300-203475, 3300-203476, 3300-203477, 3300-203478, 3300-203479, 3300-203480, 3300-203481, 3300-203482, 3300-203483, 3300-203484, 3300-203485, 3300-203486, 3300-203487, 3300-203488, 3300-203489, 3300-203490, 3300-203491, 3300-203492, 3300-203501, 3300-203502, 3300-203503, 3300-203504, 3300-203505, 3300-203506, 3300-203507, 3300-203508, 3300-203509, and 3300-203511.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0188-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0188-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-08

Product code MHX

K120616Class IISpacelabs Healthcare Qube Compact Monitor (91390Spacelabs Medical, Inc. / cleared 2012-03-29

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)