TI500 Globe-Trotter Transport System

• 2 recalls, same reason

  • Terminated Z-1052-2008 FDA Unclassified (pre-2012) ·initiated 31 Jan 2008 ·on shared 510(k) K001019
  • Terminated Z-1053-2008 FDA Unclassified (pre-2012) ·initiated 31 Jan 2008 ·on shared 510(k) K001019

  Heating failure- The power board which controls the incubator heater may not regulate the temperature properly resulting in a high temperature alarm and a loss of temperature control within the patient compartment.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K001019 ↗

FDA Product Code

FPL

Device Class

Class II

Regulation

21 CFR Part 880.5410

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K021622 Active Cleared 1 Apr 2003