Pulmonetic Systems Ltv 1200 MR Conditional Ventilator

• • Terminated Z-2205-2010 FDA Unclassified (pre-2012) ·initiated 2 Jul 2010

  CareFusion is recalling the P/N 19189-001 Patient Circuit (SPU W/O PEEP 15ft) because some of the circuit sense lines may have been reversed during the manufacturing process. If the sense lines have been reversed, immediately upon connection of the patient circuit to the ventilator and turning the ventilator on, the ventilator will begin to autocycle (with increased pressure delivered) with both

510(k) Number

K083688 ↗

FDA Product Code

CBK

Device Class

Class II

Regulation

21 CFR Part 868.5895

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Ltv 1000 Ventilator

  Class II

  FDA 510(k) K051767 Active Cleared 29 Jul 2005

• Modification to Lap Top Ventilator (Ltv)

  Class II

  FDA 510(k) K010608 Active Cleared 20 Mar 2001

• Palmtop Ventilator, Models Ptv-8, Ptv-10

  Class II

  FDA 510(k) K070594 Active Cleared 1 Aug 2007

• Automobile Lighter Power Cord

  Class II

  FDA 510(k) K060549 Active Cleared 4 May 2006

• Ltv 1200 Ventilator

  Class II

  FDA 510(k) K060647 Active Cleared 25 May 2006

• Ltv 1000

  Class II

  FDA 510(k) K984056 Active Cleared 12 Apr 1999

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