Agency classClass IIOur severity:High FDA (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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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.
Manufacturer: Spacelabs Healthcare Inc
Category: Medical Device — Patient Monitoring
Hazard: calculation-error
data-integrity

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

Distributed in 34 states:

Same manufacturer · Spacelabs Healthcare Inc

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Same hazard · calculation error