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Mrl, A Welch Allyn Company

Country not established

Devices
1
FDA recalls
5

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

Catalogue1

Newest first, rows 1-1 of 1

FDA recalls5

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

  • 2006

    • 15 Nov 2006 Z-0343-2007 Unclassified (pre-2012) Terminated Shock Delay:The monitor-defibrillator may display an 'ECG Comm' error message on the display during use, which may prevent or cause an unacceptable delay the delivery of a defibrillation shock. This delay could result in failure to resuscitate the patient. Distribution: Worldwide-USA, Australia, Belgium, Canada, Egypt, Finland, France, Germany, Ireland, Italy, Jordan, Poland, Portugal,…
      Full distribution text Worldwide-USA, Australia, Belgium, Canada, Egypt, Finland, France, Germany, Ireland, Italy, Jordan, Poland, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Sultanate of Oman, United Arab Emirates and the United Kingdom.
      Submission number: K974034
    • 30 Jun 2006 Z-1195-06 Unclassified (pre-2012) Terminated The Welch Allyn PIC 50 Defibrillators may display a 'Defib Comm' or 'Pace Comm' error message on the device display during use which may result in a terminal failure of the device to analyze the patient's ECG and deliver the appropriate therapy. Distribution: Worldwide-including USA, Puerto Rico, Australia, Belgium, Canada, China, Cyprus, France, Germany, India, Ireland,…
      Full distribution text Worldwide-including USA, Puerto Rico, Australia, Belgium, Canada, China, Cyprus, France, Germany, India, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Malaysia, Poland, Portugal, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Sultanate of Oman, Switzerland, United Arab Emirates, United Kingdom and Vietnam.
      Submission number: K974034
    • 15 Jun 2006 Z-1106-06 Unclassified (pre-2012) Terminated The Welch Allyn AED 20 Defibrillators may display a 'Defib Comm' error message on the device display during use which may result in a terminal failure of the device to analyze the patient's ECG and deliver the appropriate therapy. Distribution: Worldwide-including USA, Australia, Canada, China, France, Germany, Greece, Ireland, Israel, Italy, Latvia, Nicaragua,…
      Full distribution text Worldwide-including USA, Australia, Canada, China, France, Germany, Greece, Ireland, Israel, Italy, Latvia, Nicaragua, Norway, Poland, Portugal, Singapore, Slovenia, South Africa, South Korea, Spain, Switzerland, United Arab Emirates and the United Kingdom.
      Submission number: K002232

  • 2005

    • 28 Apr 2005 Z-0806-05 Unclassified (pre-2012) Terminated The Welch Allyn AED 20 product may display a 'Defib Comm' error message on the device display during use which may result in a terminal failure of the device to analyze the patient's ECG and deliver the appropiate therapy. Distribution: Nationwide and internationally to Australia, Canada, China, France, Germany, Ireland, Israel, Malaysia, the Middle East,…
      Full distribution text Nationwide and internationally to Australia, Canada, China, France, Germany, Ireland, Israel, Malaysia, the Middle East, New Zealand, the Philippines, Poland, Singapore, South America, South Korea, Switzerland and the United Kingdom.
      Submission number: K002232

  • 2004

    • 26 Apr 2004 Z-0918-04 Unclassified (pre-2012) Terminated A faulty component has been identified which could result in an intermittent shock button (button #3) failure on the AED10 defibrillator. Distribution: Nationwide, and internationally to the United Kingdom, Ireland, Singapore, France and South Africa. Submission number: K021168

Frequently asked questions

How many devices does Mrl, A Welch Allyn Company have in the registry?

The registry currently lists 1 device for Mrl, A Welch Allyn Company. Devices recorded under merged duplicate company entries are counted once.

Which registries list Mrl, A Welch Allyn Company's devices?

Among its 1 most recently registered device, Mrl, A Welch Allyn Company has devices listed in FDA 510(k) (1 device).

What risk classes do Mrl, A Welch Allyn Company's devices fall under?

Among its 1 most recently registered device, the classes recorded for Mrl, A Welch Allyn Company's devices are Class III. Each device page shows its own class and authorisation.

Are there FDA recall records for Mrl, A Welch Allyn Company?

FDA recall records list 5 recalls initiated by Mrl, A Welch Allyn Company, the most recent initiated on 15 Nov 2006. 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 Mrl, A Welch Allyn Company in the registry?

The most recently registered devices listed for Mrl, A Welch Allyn Company include SMARTLANK WIRELESS, MODEL 001970.

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