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FDA Medical Device Recalls (openFDA)

Zoll Medical Corporation: Zoll M Series Automated Defibrillator (AED)

Recall number
Z-1472-04
Recalling firm
Zoll Medical Corporation
Product
Zoll M Series Automated Defibrillator (AED)
Status
Terminated
Initiated
2004-08-02
Posted
2004-09-17
Terminated
2017-02-13
Reason
Visual Sreen display and audible prompt may not advise to 'Press Shock'
Root cause
Other
Action
Zoll Medical notified consignees by letter on 8/2/04 via Certified Mail. Users are advised of the problem and the softtware upgrade.
Quantity
5649 units
Distribution
Nationwide
Lot, serial or model codes
Software Versions below 34.00
510(k) numbers
["K010257"]
PMA numbers
not on file
Product code
MKT
Firm FEI
1220908
Firm city
Chelmsford
Firm state
MA
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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