Spacelabs Medical Pcis Patient Monitors

• • Terminated Z-3036-2011 FDA Unclassified (pre-2012) ·initiated 17 Sep 2010 ·via K972282, on the same 510(k)

  Monitor may reset repeatedly which can result in a loss of patient monitoring for several minutes. Cause is a software problem.

• 3 recalls, same reason

  • Terminated Z-0648-2010 FDA Unclassified (pre-2012) ·initiated 6 Nov 2009 ·via K972282, on the same 510(k)
  • Terminated Z-0649-2010 FDA Unclassified (pre-2012) ·initiated 6 Nov 2009 ·via K972282, on the same 510(k)
  • Terminated Z-0647-2010 FDA Unclassified (pre-2012) ·initiated 6 Nov 2009 ·via K972282, on the same 510(k)

  Potential for monitor to shut down and not being able to power on again.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

510(k) Number

K972282 ↗

FDA Product Code

DSI

Device Class

Class II

Regulation

21 CFR Part 870.1025

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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See all devices from Spacelabs Medical, Inc. →