🔍 RecallPedia

Velara Generator with an old Firmware version used with the Philips Integris BH5000

Class I - Dangerous
🏥 Medical Devices Recalled: December 9, 2016 Philips Electronics North America Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    Velara Generator with 12nc number: 989000070011, 989000070122, 989000070123, 989000070124, 989000070125, 989000070126, 989000070321
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Philips Electronics North America Corporation
Reason for Recall:
System may lock up.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Velara Generator with an old Firmware version used with the Philips Integris BH5000

Product Codes/Lot Numbers:

Velara Generator with 12nc number: 989000070011, 989000070122, 989000070123, 989000070124, 989000070125, 989000070126, 989000070321

Distribution:

Distributed in: US, AL, CA, DC, IL, GA, KS, MD, MO, NC, NY, OH, PA, RI, SC, TX, WA

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1062-2017

Related Recalls

Xper Flex Cardio Physiomonitoring System, Software versions 1.5.16.0322 and 1.6.1.0390, Model Numbers 453564241901, 453564241911, 453564483321, 453564483331, 453564621791, 453564621801, 453564669081

Philips Electronics North America

Class I - Dangerous

There are 3 issues: 1) Under certain conditions, real time waveforms may not be accurately plotted or displayed. 2) The oxygen saturation (SpO2) numeric value displayed on the device may freeze. 3) In auto cycle mode, if the NIBP communication is lost, the pump would not cycle and the non-invasive blood pressure (NIBP) numeric value displayed on the device would not update.

Nov 15, 2018 Diagnostic Equipment View Details →

IntelliVue MX40 Patient Monitor, Model Nos. 865350, 865351, 865352, 867146 - Product Usage: Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals.

Philips Electronics North America

Class I - Dangerous

A problem has been detected in the Philips IntelliVue MX4O that, if it were to occur, could affect the performance of the equipment. The volume of the MX4O speaker in these devices may be diminished or not audible above 4,500 feet when operating in Monitor Mode. These devices may intermittently exhibit Speaker Malfunct INOP messages after the Power On Self-Test. The issue is only apparent when the device is being used in Monitor Mode at an altitude of greater than 4,500 feet.

Oct 10, 2018 Diagnostic Equipment Nationwide View Details →

Philips HeartStart FR3 Defibrillator, Model: 861388, 861389 Product Usage: The HeartStart FR3 is used to treat suspected victims of ventricular fibrillation (VF), the most common cause of sudden cardiac arrest (SCA), and certain ventricular tachycardia (VTs). Both models are used with disposable pads applied to potential victims of SCA with the following symptoms: 1) Unresponsiveness 2) Absence of normal breathing The HeartStart FR3 is intended for adults and children over 55 pounds (25kg) or 8 years old. Both models 861388 and 861389 are also intended for children under 55 pounds (25kg) or 8 years old when used with the optional Infant/Child Key. If the Infant/Child Key is not available, or you are uncertain of the child s age or weight, do not delay treatment. Device not sterile and not implantable.

Philips Electronics North America

Class I - Dangerous

Automated external defibrillators may not fully meet IPx5 water ingress specification. The device may fail to function should water intrusion occur.

Oct 10, 2018 Implants & Prosthetics Nationwide View Details →