Recall Z-2343-2016— Spacelabs Healthcare Inc

Name: FDA recall Z-2343-2016
Creator: U.S. Food and Drug Administration
Published: 2016-07-01

Class II · Terminated

Class II FDA medical device recall by Spacelabs Healthcare Inc, initiated 2016-07-01, terminated 2017-05-22. It names one FDA 510(k) clearance: K103142. Product: 91496 Ultraview SL Command Module, Options A, B, C, and I. Option A: ECG/Respiration, SpO2, Temperature x2 & adult/neonate NIBP. Option B: ECG/Respiration, Invasive Pressure x2, SpO2, Temperature x2 & adult/neonate NIBP. Option C: ECG/Respiration, Invasive Pressure x4, SpO2, Cardiac Output, Temperature x2 & adult/neonate NIBP. Option I: SpO2, Temperature x2, & adult/neonate NIBP.. Reason: The firm has received multiple reports of the Non-Invasive Blood Pressure (NIBP) parameter becoming non-functional with an associated message (No Reading). In addition, there is one of the following three error messages: Inflate Error, HW Error, or No Data..

Recalling firm: Spacelabs Healthcare Inc
Classification: Class II
Status: Terminated
Initiated: 2016-07-01
Terminated: 2017-05-22
Firm location: Snoqualmie, WA, United States

510(k) clearances named in this recall

1 on FDA's record

K103142 — SPACELABS MULTI-PARAMETER MODULESpacelabs Healthcare, Inc.·cleared 2011-03-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

91496 Ultraview SL Command Module, Options A, B, C, and I. Option A: ECG/Respiration, SpO2, Temperature x2 & adult/neonate NIBP. Option B: ECG/Respiration, Invasive Pressure x2, SpO2, Temperature x2 & adult/neonate NIBP. Option C: ECG/Respiration, Invasive Pressure x4, SpO2, Cardiac Output, Temperature x2 & adult/neonate NIBP. Option I: SpO2, Temperature x2, & adult/neonate NIBP.

Reason for recall

The firm has received multiple reports of the Non-Invasive Blood Pressure (NIBP) parameter becoming non-functional with an associated message (No Reading). In addition, there is one of the following three error messages: Inflate Error, HW Error, or No Data.

Data sourced from openFDA. This site is unofficial and independent of the FDA.