Recall Z-2035-2019— Spacelabs Healthcare, Inc.

Name: FDA recall Z-2035-2019
Creator: U.S. Food and Drug Administration
Published: 2019-01-28

Class II · Terminated

Class II FDA medical device recall by Spacelabs Healthcare, Inc., initiated 2019-01-28, terminated 2022-02-24. It names one FDA 510(k) clearance: K110779. Product: Spacelabs Healthcare Smart Disclosure System, Model 92810, a component of the Intesys Clinical Suite (ICS) G2.. Reason: Several reports were received that patient records were printed with the correct patient demographics but containing another patient's waveforms..

Recalling firm: Spacelabs Healthcare, Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-01-28
Terminated: 2022-02-24
Firm location: Snoqualmie, WA, United States

510(k) clearances named in this recall

1 on FDA's record

K110779 — SPACELABS SMART DISCLOSURE SYSTEMSpacelabs Healthcare·cleared 2011-04-19

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

Spacelabs Healthcare Smart Disclosure System, Model 92810, a component of the Intesys Clinical Suite (ICS) G2.

Reason for recall

Several reports were received that patient records were printed with the correct patient demographics but containing another patient's waveforms.

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