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[Enforcement] Philips Medical Systems, Inc. — Philips HeartStart XL+ Defibrillator/Moni...

Mar 5, 2014
Published: 2014-03-05Captured: 2026-02-09Philips Medical Systems, Inc.Product: Philips HeartStart XL+ Defibrillator/Monitor Model: 861290 The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in the operation of the device and qua...

FDA issued a Class II enforcement action. Affects Philips Medical Systems, Inc.. Reason: HeartStart XL+ battery charge time to 100% capacity at 35¿C (95¿F) is slightly longer than the specified 3 hour duration.

  • •Classification: Class II
  • •Firm: Philips Medical Systems, Inc.
  • •Status: Terminated
  • •Distribution: Worldwide Distribution - USA (nationwide) including Puerto Rico and the countries of ALGERIA ANGOLA ARG...
Reason

HeartStart XL+ battery charge time to 100% capacity at 35¿C (95¿F) is slightly longer than the specified 3 hour duration as stated in the labeling

Status:Terminated
Distribution

Worldwide Distribution - USA (nationwide) including Puerto Rico and the countries of ALGERIA ANGOLA ARGENTINA AUSTRALIA AUSTRIA AZERBAIJAN BAHRAIN BELGIUM BOLIVIA BULGARIA CANADA CHILE CHINA COLOMB...

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Philips HeartStart XL+ Defibrillator/Monitor Model: 861290 The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced life support or defibrillation. When operating as a semi-automatic external defibrillator in AED Mode, the HeartStart XL+ is suitable for use by medical personnel trained in basic life support that includes the use of an AED. When operating in Monitor, Manual Defibrillation or Pacing modes, the HeartStart XL+ is suitable for use by healthcare professionals trained in advance life support. | TrueMedDevice