Warm Air Warming Unit

• • Terminated Z-0781-2010 FDA Unclassified (pre-2012) ·initiated 14 Nov 2009

  Product is labeled as "Sterile". It was observed that incomplete seals were created in the packaging materials during production. When the seal is compromised, the sterility of the product inside the package cannot be assured.

• • Terminated Z-0035-2010 FDA Unclassified (pre-2012) ·initiated 16 Feb 2009

  The blower on the WarmAir 135 Warming Unit may overheat. Resistance in a connector between circuit board and wiring harness results in excessive heat that may melt connector or deform the outer casing of the blower unit.

• • Terminated Z-0374-05 FDA Unclassified (pre-2012) ·initiated 5 Nov 2004 ·on shared 510(k) K942599

  Burning smell, burned microprocessor board. The firm is modifying the connectors and wiring gauge configuration of the device.

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

510(k) Number

K942599 ↗

FDA Product Code

DWJ

Device Class

Class II

Regulation

21 CFR Part 870.5900

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Hemotherm Model 400CE Cooler/Heater System

  Class II

  FDA 510(k) K122813 Active Cleared 18 Dec 2012

• Norm-O-Temp Hyperthermia System Incliding Blankets/Pads

  Class II

  FDA 510(k) K120081 Active Cleared 17 Feb 2012

• Warmair Model 135 Hyperthermia System Including Filteredflo Blankets

  Class II

  FDA 510(k) K123946 Active Cleared 17 Jan 2013

• Disposable Temperature Probes/Sensors and Instrument Cables

  Class II

  FDA 510(k) K070339 Active Cleared 26 Sep 2007

• Warm Air Model 135 Hyperthermia System and Blankets

  Class II

  FDA 510(k) K101148 Active Cleared 1 Oct 2010

• Warm Air Hypertheermia System (Models #130 and #133)

  Class II

  FDA 510(k) K942790 Active Cleared 24 Jan 1995

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