FDA Device recall Z-1092-2016
Spacelabs Healthcare Xhibit Central Station, Model 96102 is used to provide clinicians with central monitoring of patient data for those pa…
- FDA Device
- Class II
- terminated
- Published 2016-03-16
On 2016-03-16 the FDA classified a Class II recall of Spacelabs Healthcare Xhibit Central Station, Model 96102 is used to provide clinicians with central monitoring of patient data for those pa… by Spacelabs Healthcare, citing 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 Surfa….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1092-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-02-26 |
| Published | 2016-03-16 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Spacelabs Healthcare |
| Distribution | 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 |
Product
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.
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.
Identifiers
| code_info | **SERIAL NUMBERS OF UNITS DISTRIBUTED IN THE US******* SALA0315F01025, SLA0114F00426, SLA0114F00434, SLA0114F00435,…**SERIAL NUMBERS OF UNITS DISTRIBUTED IN THE US******* SALA0315F01025, SLA0114F00426, SLA0114F00434, SLA0114F00435, SLA0114F00444, SLA0114F00445, SLA0114F00446, SLA0114F00447, SLA0114F00448, SLA0114F00449, SLA0114F00451, SLA0114F00452, SLA0114F00453, SLA0114F00454, SLA0114F00457, SLA0114F00458, SLA0114F00460, SLA0114F00461, SLA0114F00462, SLA0114F00463, SLA0114F00464, SLA0114F00466, SLA0114F00468, SLA0114F00469, SLA0115F00916, SLA0115F00917, SLA0115F00918, SLA0115F00919, SLA0115F00921, SLA0115F00923, SLA0115F00924, SLA0115F00925, SLA0115F00926, SLA0115F00927, SLA0115F00928, SLA0115F00929, SLA0115F00931, SLA0115F00933, SLA0115F00934, SLA0115F00935, SLA0115F00936, SLA0115F00937, SLA0115F00948, SLA0115F00950, SLA0115F00955, SLA0115F00959, SLA0115F00961, SLA0115F00963, SLA0115F00964, SLA0115F00968, SLA0115F00969, SLA0115F00971, SLA0115F00972, SLA0115F00976, SLA0115F00979, SLA0115F00983, SLA0115F00986, SLA0115F00987, SLA0115F00991, SLA0115F00993, SLA0124F00910, SLA0214F00484, SLA0214F004 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1092-2016%22
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