Recall Z-1092-2016 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Spacelabs Healthcare Inc
Spacelabs Healthcare Xhibit Central Station, Model 96102 is used to provide clinicians with central monitoring of patient data for those patients connected to networked Spacelabs Healthcare patient monitors and telemetry transmitters.
| Date | Feb 26, 2016 |
| Status | Terminated |
| Reason | The firm has received one report of values for patient height and weight being switched when input at the Xhibit Central Station, Model 96102, causing a bedside monitor Body Surface Area (BSA) calculation to be in error. |
| Root cause | Software in the Use Environment |
| Action | Spacelabs sent the letter Urgent Medical Device Correction -Spacelabs Healthcare Inc. - Xhibit Central Station, Model 96102, dated 26 February 2016 to US consignees. The firm will send a notification letter to international consignees on March 4, 2016. Consignees who have any questions about this corrective action, please contact Spacelabs at 1-800-522-7025 and select 2 for Technical Support. |
| Quantity | total 1075 units (614 units in the US and 461 outside the US) |
| Distribution | distributed in AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MI, MN, MO, MS, MT, NC, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WY and Guam and in the following countries AFGHANISTAN, ARGENTINA, AUSTRALIA, BAHRAIN, BOLIVIA, BRAZIL, BRUNEI DARUSSALAM, CANADA, CHILE, CHINA, COLOMBIA, CO |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122146 | XHIBIT CENTRAL STATION, MODEL 96102 Spacelabs Healthcare, Apr 22, 2013 |