🔍 RecallPedia

IntelliVue X3 Patient Monitor.

Class I - Dangerous
🏥 Medical Devices Recalled: November 17, 2017 Philips Electronics North America Diagnostic Equipment

What Should You Do?

  1. Check if you have this product:
    Model 867030 - All devices shipped from June 2017 (Updated 8-14-18) Serial No. DE61102743 DE61103908 DE61102877 DE61105176 DE61102652 DE61102659 DE61104847 DE61101457 DE61101460 DE61100472 DE61101176 DE61100535 DE61100101 DE61100544 DE61101308 DE61101569 DE61101001 DE61101266 DE61100411 DE61101279 DE61101110 DE61100173 DE61101283 DE61100511 DE61100153 DE61101302 DE61101480 DE61100832 DE61100139 DE61100176 DE61100845 DE61100201 DE61100558 DE61100243 DE61100466 DE61100240 DE61100293 DE61100678 DE61100910 DE61100202 DE61101132 DE61100561 DE61100172 DE61101010 DE61101158 DE61101409 DE61101427 DE61101218 DE61100700 DE61100526 DE61101004 DE61100927 DE61101441 DE61100755 DE61100753 DE61101456 DE61101462 DE61101463 DE61101464 DE61101465 DE61101466 DE61101470 DE61101471 DE61101475 DE61101476 DE61101478 DE61101479 DE61101481 DE61101483 DE61101484 DE61101486 DE61101487 DE61101489 DE61101494 DE61101496 DE61101501 DE61101507 DE61101508 DE61101512 DE61101516 DE61101521 DE61100469 DE61101172 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DE61100707 DE61100556 DE61100160 DE61100175 DE61101007 DE61101014 DE61101015 DE61101017 DE61101018 DE61101020 DE61101021 DE61101022 DE61101027 DE61101029 DE61101030 DE61101031 DE61101033 DE61101040 DE61101041 DE61101043 DE61101044 DE61101045 DE61101046 DE61101048 DE61101049 DE61101051 DE61101052 DE61101053 DE61101054 DE61101055 DE61101056 DE61101057 DE61101058 DE61101059 DE61101060 DE61101061 DE61101063 DE61101064 DE61101065 DE61101066 DE61101067 DE61101068 DE61101069 DE61101070 DE61101098 DE61101102 DE61101105 DE61101106 DE61101112 DE61101114 DE61101115 DE61101118 DE61101134 DE61101161 DE61101492 DE61101498 DE61101505 DE61101509 DE61101510 DE61101523 DE61101526 DE61101527 DE61101540 DE61101541 DE61101543 DE61101545 DE61101548 DE61101562 DE61101567 DE61101571 DE61101573 DE61101589 DE61101592 DE61101593 DE61101595 DE61101598 DE61101408 DE61101410 DE61101411 DE61101413 DE61101414 DE61101415 DE61101416 DE61101418 DE61101419 DE61101420 DE61101421 DE61101422 DE61101423 DE61101424 DE61101425 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  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:
The NBP measurement of Intellivue X3 Patient Monitor shows intermittently only mean values instead of the diastolic and systolic blood pressure values. This is caused by a falsely detected NBP cuff, which is leading to wrong internal NBP setting. Furthermore, occasionally the Monitor shows the Check Touch Input message and the monitor is inoperable with the touch interface.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

IntelliVue X3 Patient Monitor.

Product Codes/Lot Numbers:

Model 867030 - All devices shipped from June 2017 (Updated 8-14-18) Serial No. DE61102743 DE61103908 DE61102877 DE61105176 DE61102652 DE61102659 DE61104847 DE61101457 DE61101460 DE61100472 DE61101176 DE61100535 DE61100101 DE61100544 DE61101308 DE61101569 DE61101001 DE61101266 DE61100411 DE61101279 DE61101110 DE61100173 DE61101283 DE61100511 DE61100153 DE61101302 DE61101480 DE61100832 DE61100139 DE61100176 DE61100845 DE61100201 DE61100558 DE61100243 DE61100466 DE61100240 DE61100293 DE61100678 DE61100910 DE61100202 DE61101132 DE61100561 DE61100172 DE61101010 DE61101158 DE61101409 DE61101427 DE61101218 DE61100700 DE61100526 DE61101004 DE61100927 DE61101441 DE61100755 DE61100753 DE61101456 DE61101462 DE61101463 DE61101464 DE61101465 DE61101466 DE61101470 DE61101471 DE61101475 DE61101476 DE61101478 DE61101479 DE61101481 DE61101483 DE61101484 DE61101486 DE61101487 DE61101489 DE61101494 DE61101496 DE61101501 DE61101507 DE61101508 DE61101512 DE61101516 DE61101521 DE61100469 DE61101172 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Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1315-2018

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 →