The Recall Desk
HighFDA (Devices)·Z-1092-2016·Announced 2016-03-16

Spacelabs Xhibit Central Station Recalled for Height and Weight Input Error

Spacelabs Healthcare is recalling Xhibit Central Station units because patient height and weight values may be switched, causing incorrect Body Surface Area calculations.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a risk-of-harm product (medical monitoring device) where a calculation error could impact patient care, but no injuries or illnesses have been reported.

Plain-English summary

Spacelabs Healthcare Inc is recalling the Xhibit Central Station, Model 96102, a medical device used to provide clinicians with central monitoring of patient data. The recall involves 1,075 units, with 614 units distributed in the United States and 461 units distributed outside the United States.

The firm received one report that patient height and weight values were switched when input at the central station. This error caused the bedside monitor's Body Surface Area (BSA) calculation to be incorrect. The affected units were distributed across 33 US states, Guam, and numerous countries worldwide.

Healthcare facilities should check their serial numbers against the list provided by the FDA and contact Spacelabs Healthcare for instructions on how to resolve the issue.

The recalled product

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.

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • **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

Distribution