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Medtronic Emergency Response Systems, Inc.

United StatesFDA applicant, unverified

Devices
6
FDA recalls
21

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Medtronic Emergency Response Systems, Inc. makes

The company manufactures automated external defibrillators (AEDs) and advanced cardiac monitors, including standalone and semi-automated models for emergency response and pre-hospital use. Products include portable defibrillators with monitoring capabilities, such as the LIFEPAK 12 and LIFEPAK 20, as well as automated models like the LIFEPAK 500. Additional systems like the LIFENET Exchange support data transfer for clinical integration. The portfolio also includes legacy defibrillator models, such as the LIFEPAK Model 1000.

These devices are regulated under the US FDA as Class II and Class III medical devices, requiring premarket notification (510(k)) clearance for most models. The company’s products are listed in the FDA’s 510(k) database, reflecting their authorised status for commercial distribution in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue6

Newest first, rows 1-6 of 6

FDA recalls21

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 21 recalls initiated by Medtronic Emergency Response Systems, Inc., the earliest on 2005-01-15 and the most recent on 2007-06-13. By recorded status: 21 terminated. The reasons filed fall into these groups: software or firmware, sterility or contamination and electrical or power. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Showing the 10 most recent of 21 recalls.

  • 2007

    • 13 Jun 2007 Z-1148-2007 Unclassified (pre-2012) Terminated Reduced Shock- the device may deliver 100 Joule (J) to a patient, which is less than the recommended factory minimum default setting of 200 J. Distribution: Worldwide Submission number: K955854
    • 27 Apr 2007 Z-0925-2007 Unclassified (pre-2012) Terminated White Screen Lock up: LifePak 20 defibrillators with software version 48 or version 52 may experience an intermittent timing issue during the power on sequence. This may lock up the device resulting in the monitor screen going white, and may cause a potential delay or prevention of shock treatment. Distribution: Distribution is Worldwide. Devices are used by healthcare providers in hospital or healthcare clinic settings. Submission number: K012274
    • 30 Mar 2007 Z-0886-2007 Unclassified (pre-2012) Terminated Defibrillator internal battery cell may contain a short which could reduce battery capacity and cause the device to shut down without warning while operating on backup (DC) battery power. Distribution: Distribution is worldwide. The device is designed to be used in healthcare provider facilities such as hospitals and…
      Full distribution text Distribution is worldwide. The device is designed to be used in healthcare provider facilities such as hospitals and clinic settings.
      Submission number: K012274
    • 30 Mar 2007 Z-0887-2007 Unclassified (pre-2012) Terminated Defibrillator internal battery cell may contain a short which could reduce battery capacity and cause the device to shut down without warning while operating on backup (DC) battery power. Distribution: Distribution is worldwide. The device is designed to be used in healthcare provider facilities such as hospitals and…
      Full distribution text Distribution is worldwide. The device is designed to be used in healthcare provider facilities such as hospitals and clinic settings.
    • 2 Mar 2007 Z-0671-2007 Unclassified (pre-2012) Terminated LIFEPAK CR Plus defibrillators with software version 1.16 or lower may miscalculate the HLC battery capacity and result in the CHARGE-PAK battery charger icon/indicator to display and falsely indicate battery needs replacement. Distribution: Distribution is worldwide. The device is designed for non-professional users and are primarily used in public access…
      Full distribution text Distribution is worldwide. The device is designed for non-professional users and are primarily used in public access defibrillator environments such as airports, schools, or public libraries.
      Submission number: K011144

  • 2006

    • 5 Oct 2006 Z-0836-2007 Unclassified (pre-2012) Terminated Premature battery depletion due to electrical component failure Distribution: Distribution is worldwide. The device is designed for non-professional users and are primarily used in public access…
      Full distribution text Distribution is worldwide. The device is designed for non-professional users and are primarily used in public access defibrillator environments such as airports, schools, and public libraries.
      Submission number: K011144
    • 5 Oct 2006 Z-0837-2007 Unclassified (pre-2012) Terminated Premature battery depletion due to electrical component failure Distribution: Distribution is worldwide. The device is designed for non-professional users and are primarily used in public access…
      Full distribution text Distribution is worldwide. The device is designed for non-professional users and are primarily used in public access defibrillator environments such as airports, schools, and public libraries.
      Submission number: K011144
    • 30 Aug 2006 Z-1502-06 Unclassified (pre-2012) Terminated Devices with v38 system software do not display a ''LOW BATTERY: CONNECT TO AC POWER'' message when the monitor is on backup (DC) battery power and may shut down without warning. Distribution: Units were distributed worldwide to hospitals and medical centers. Submission number: K012274
    • 22 Mar 2006 Z-0710-06 Unclassified (pre-2012) Terminated Therapy connectors may have connector sockets that do not meet design specs - short drill depth. Interruption of the connections may cause unexpected, intermittent or complete loss of pacing and defibrillation functions. Distribution: Nationwide, and Canada, Netherlands, Germany, Australia, Guam, Hong Kong, New Zealand, New Caledonia, Argentina, Brazil,…
      Full distribution text Nationwide, and Canada, Netherlands, Germany, Australia, Guam, Hong Kong, New Zealand, New Caledonia, Argentina, Brazil, Chile, Costa Rica, Mexico, Uruguay, Venezuela. Domestic distribution includes hospitals, clinics,
      Submission number: K010918
    • 22 Mar 2006 Z-0711-06 Unclassified (pre-2012) Terminated Therapy connectors may have connector sockets that do not meet design specs - short drill depth. Interruption of the connections may cause unexpected, intermittent or complete loss of pacing and defibrillation functions. Distribution: Nationwide, and Canada, Netherlands, Germany, Australia, Guam, Hong Kong, New Zealand, New Caledonia, Argentina, Brazil,…
      Full distribution text Nationwide, and Canada, Netherlands, Germany, Australia, Guam, Hong Kong, New Zealand, New Caledonia, Argentina, Brazil, Chile, Costa Rica, Mexico, Uruguay, Venezuela. Domestic distribution includes hospitals, clinics,
      Submission number: K012274
Show all 21 recalls

  • 2006

    • 16 Mar 2006 Z-0295-2007 Unclassified (pre-2012) Terminated LIFEPAK 20 may lock-up when attempting to power-up on DC within 2 seconds after removing AC power. Distribution: Devices were distributed to hospitals and clinics worldwide. Submission number: K012274
    • 1 Feb 2006 Z-0546-06 Unclassified (pre-2012) Terminated Component leads may have intermittent connection to the printed circuit board assembly pads - which could render the device inoperative. Distribution: Devices were distributed domestically to first responder type consignees and internationally to distributors.
    • 31 Jan 2006 Z-0547-06 Unclassified (pre-2012) Terminated One of the printed circuit board assemblies may be contaminated with solder flux which can cause a short that may render the device inoperative. Distribution: Units were distributed worldwide to public access environments.
    • 31 Jan 2006 Z-0548-06 Unclassified (pre-2012) Terminated One of the printed circuit board assemblies may be contaminated with solder flux which can cause a short that may render the device inoperative. Distribution: Units were distributed worldwide to public access environments.

  • 2005

    • 2 Sep 2005 Z-0116-06 Unclassified (pre-2012) Terminated Potential for voltage pins in connector of therapy cable to break. Distribution: Devices were distributed worldwide. Submission number: K012274
    • 2 Sep 2005 Z-0117-06 Unclassified (pre-2012) Terminated Potential for voltage pins in connector of therapy cable to break. Distribution: Devices were distributed worldwide. Submission number: K012274
    • 12 Jul 2005 Z-0004-06 Unclassified (pre-2012) Terminated Some hard shell carry case for LIFEPAK 500 and LIFEPAK CR Plus automated external defibrillators may have blocked pressure vent which may make it difficult to open the case after a sudden decrease in altitude (such as in aircraft landng or mountain descent). Distribution: Cases were distributed nationwide and internationally. Submission number: K010918
    • 12 Jul 2005 Z-0005-06 Unclassified (pre-2012) Terminated Some hard shell carry case for LIFEPAK 500 and LIFEPAK CR Plus automated external defibrillators may have blocked pressure vent which may make it difficult to open the case after a sudden decrease in altitude (such as in aircraft landng or mountain descent). Distribution: Cases were distributed nationwide and internationally.
    • 17 Jun 2005 Z-0984-05 Unclassified (pre-2012) Terminated The defibrillator may not operate if the device is turned on during an AC Loss Alert. Distribution: Devices were distributed to hospitals and medical centers worldwide. Submission number: K012274
    • 3 Feb 2005 Z-0562-05 Unclassified (pre-2012) Terminated Potential to not detect patients at the low end of the patient impedance range. Distribution: Devices were distributed to 750 domestic consignees dn 16 international consignees.
    • 15 Jan 2005 Z-0495-05 Unclassified (pre-2012) Terminated The LIFEPAK 12 biphasic defibrillator/ monitors may deliver inappropriate energy levels and fail to escalate energy levels when configured to do so. Distribution: 28,835 devices were shipped to 6874 domestic consignees. Submission numbers: K040775, K991910

Frequently asked questions

How many devices does Medtronic Emergency Response Systems, Inc. have in the registry?

The registry currently lists 6 devices for Medtronic Emergency Response Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Medtronic Emergency Response Systems, Inc.'s devices?

Among its 6 most recently registered devices, Medtronic Emergency Response Systems, Inc. has devices listed in FDA 510(k) (6 devices).

What risk classes do Medtronic Emergency Response Systems, Inc.'s devices fall under?

Among its 6 most recently registered devices, the classes recorded for Medtronic Emergency Response Systems, Inc.'s devices are Class II and Class III. Each device page shows its own class and authorisation.

Are there FDA recall records for Medtronic Emergency Response Systems, Inc.?

FDA recall records list 21 recalls initiated by Medtronic Emergency Response Systems, Inc., the most recent initiated on 13 Jun 2007. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Medtronic Emergency Response Systems, Inc. in the registry?

The most recently registered devices listed for Medtronic Emergency Response Systems, Inc. include LIFEPAK 12 DEFIBRILLATOR/MONITOR, LIFENET EXCHANGE SYSTEM, LIFEPAK, MODEL 1000 and LIFEPAK 20 DEFIBRILLATOR/ MONITOR.

Generated automatically from registry data and not verified by a human reviewer.