Spacelabs Medical Patient Monitors

• • Terminated Z-2707-2014 FDA Class II ·initiated 26 Aug 2014

  The clinician did not realize the monitor was in END CASE mode and was expecting audible alarms. Visual alarms continue to work normally. The firm performed a retrospective analysis of all recalls since 2011 and discovered 222 additional serial numbers were missed and were not included in the previous recall under RES 59456 (recall number Z-3032-2011).

• • Terminated Z-3032-2011 FDA Unclassified (pre-2012) ·initiated 8 Jul 2011

  The clinician did not realize the monitor was in END CASE mode and was expecting audible alarms. Visual alarms continue to work normally.

• • Terminated Z-2134-2011 FDA Unclassified (pre-2012) ·initiated 24 Mar 2011

  The circuit that supplies backup power to the modules in the Medical Patient Monitor, Model 91387, is not working. If there is a power interruption, the three-minute backup may not be operational and customers may lose any changes they have made to the alarm settings.

510(k) Number

K102422 ↗

FDA Product Code

MHX

Device Class

Class II

Regulation

21 CFR Part 870.1025

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Spacelabs Medical Model 90481 EEG Module

  Class II

  FDA 510(k) K932842 Active Cleared 2 Mar 1994

• Spacelabs Medical ECG Module (Model 90492)

  Class II

  FDA 510(k) K942058 Active Cleared 17 May 1995

• Spacelabs Medical Bispectral Index (Bisx) Analysis Module 91482 and Accessories Model-91842

  Class II

  FDA 510(k) K060900 Active Cleared 23 Jun 2006

• Spacelabs Medical Full Disclosure System, Model 91810

  Class II

  FDA 510(k) K063490 Active Cleared 15 Mar 2007

• Spacelabs Healthcare Qube Compact Monitor (91390 Open recall

  Class II

  FDA 510(k) K120616 Active Cleared 29 Mar 2012

• Spacelabs Medical Patient Monitor

  Class II

  FDA 510(k) K930095 Active Cleared 3 Sep 1993

See all devices from Spacelabs Medical, Inc. →