Spacelabs Healthcare elance Vital Signs Monitor, Model… recallZ-0188-2014 · Spacelabs Healthcare, Llc · initiated Oct 17, 2013
Class II Terminated All recalls posted in November 2013
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Spacelabs Healthcare, Llc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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.
Recall details
- Recall number
- Z-0188-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Oct 17, 2013
- Posted by the FDA
- Nov 8, 2013
- Recalling firm
- Spacelabs Healthcare, Llc
- Quantity
- 89 units total (1 in US and 88 International)
- Product code
- MHX
- FDA submissions
- K120616
- Distribution
- Worldwide Distribution-Distributed in Puerto Rico and the countries of France, Indonesia, Korea, Nicaragua, Philippines, and Taiwan.
Product description
Spacelabs Healthcare elance Vital Signs Monitor, Model 93300, with Option S. It is a patient monitor with arrhythmia detection or alarms.
Code information (models, lots, serial numbers)
Show the full code information (1k characters)
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.
Other devices under the same FDA submission
3 devices cleared under K120616 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Qube Qube Compact MonitorSpacelabs Healthcare (Washington), Inc · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)3 recalls3 reports
- qube 91390Spacelabs Healthcare (Washington), Inc · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)21 reports
- qube miniSpacelabs Healthcare (Washington), Inc · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)4 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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