FDA Medical Device Recalls (openFDA)
Spacelabs Healthcare, Llc: Spacelabs Healthcare elance Vital Signs Monitor, Model 93300, with Option S. It is a patient monitor with arrhythmia detection or alarms.
- Recall number
- Z-0188-2014
- Recalling firm
- Spacelabs Healthcare, Llc
- Product
- Spacelabs Healthcare elance Vital Signs Monitor, Model 93300, with Option S. It is a patient monitor with arrhythmia detection or alarms.
- Status
- Terminated
- Initiated
- 2013-10-17
- Posted
- 2013-11-08
- Terminated
- 2014-02-25
- Reason
- 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
- 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
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K120616"]
- PMA numbers
- not on file
- Product code
- MHX
- Firm FEI
- 3010157426
- Firm city
- Snoqualmie
- Firm state
- WA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28