Devices

Device Recall AED 10

Model / Serial
Blown fuse serial numbers: 008577 - 013143 inclusive. Voice prompt serial numbers: 002002 - 008286 inclusive, and 008289 008291 008293 008296 008297 008298 008299 008300 008301 008302 008303 008304 008305 008306 008307 008308 008309 008310 008311 008312 008313 008314 008315 008316 008322 008323 008324 008325 008326 008327 008328 008329 008330 008331 008332 008333 008334 008335 008336 008337 008339 008340 008362 008363 008364 008365 008366 008367 008368 008369 008370 008372 008373 008374 008375 008376 008377 008378 008379 008402 008403 008404 008405 008406 008407 008411 008413 008414 008415 008416 008417 008418 008419 008420 008421 008422 008423 008424 008425 008426 008427 008428 008429 008430 008431 008432 008435 008446 008524 008525 008583 008656 008671 008712 008714 008724 008742 008743 008744 008792 008856 008864 008911 008913 008943 008988 009007 009009 009010 009015 009016 009017 009066 009067 009070 009071 009072 009073 009074 009075 009076 009079 009081 009083 009085 009086 009087 009122 009123 009124 009126 009127 009128 009129 009130 009139 009715 009813 010108 010168 012603 013659 013665 013727 016604 019508 020910 020911 020912 022356 and 027224.
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
No
Distribution
Worldwide distribution.
Product Description
Welch Allyn AED 10 automated external defibrillator and MRL Jumpstart (collectively "AED 10")
Manufacturer
Welch Allyn Protocol, Inc
1 Event
- Recall of Device Recall AED 10

Manufacturer

Welch Allyn Protocol, Inc

Manufacturer Address
Welch Allyn Protocol, Inc, 8500 Sw Creekside Pl, Beaverton OR 97008
Manufacturer Parent Company (2017)
Hill-Rom Holdings, Inc
Source
USFDA

2 devices with a similar name

Learn more about the data here

Device Recall AED 10

Model / Serial
Software version 2.02 or lower. The ECG analysis/noise issue involves all units manufactured before January 2006 when a design/component change was made.
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
No
Distribution
Worldwide Distribution.
Product Description
Welch Allyn AED 10 automated external defibrillator and MRL Jumpstart (collectively "AED 10")
Manufacturer
Welch Allyn Protocol, Inc

Device Recall AED 10

Model / Serial
Affected serial numbers are listed on http://www.welchallyn.com/AED10Recall
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
No
Distribution
Worldwide distribution.
Product Description
Welch Allyn AED 10 automated external defibrillator and MRL Jumpstart (collectively "AED 10")
Manufacturer
Welch Allyn Protocol, Inc

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Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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