Recall Z-0188-2014 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Spacelabs Healthcare, Llc
Spacelabs Healthcare elance Vital Signs Monitor, Model 93300, with Option S. It is a patient monitor with arrhythmia detection or alarms.
| Date | Nov 8, 2013 (initiated Oct 17, 2013) |
| Status | Terminated |
| 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 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120616 | SPACELABS HEALTHCARE QUBE COMPACT MONITOR (91390 Spacelabs Medical, Inc., Mar 29, 2012 |