FDA Medical Device Recalls (openFDA)
Zoll Circulation, Inc.: AutoPulse Resuscitation System Model 100, Mfg by:Zoll Circulation Sunnyvale, CA. The AutoPulse Model 100 Automatic Mechanical Chest compressor is intended to be used as an adjunct to manual CPR, on adult patients only, in cases of clinical death as defined by lack of spontaneous breathing and pulse.
- Recall number
- Z-0658-2013
- Recalling firm
- Zoll Circulation, Inc.
- Product
- AutoPulse Resuscitation System Model 100, Mfg by:Zoll Circulation Sunnyvale, CA. The AutoPulse Model 100 Automatic Mechanical Chest compressor is intended to be used as an adjunct to manual CPR, on adult patients only, in cases of clinical death as defined by lack of spontaneous breathing and pulse.
- Status
- Terminated
- Initiated
- 2012-08-08
- Posted
- 2013-01-09
- Terminated
- 2014-05-12
- Reason
- Complaints associated with an unexpected stop in AutoPulse compressions.
- Root cause
- Employee error
- Action
- Zoll sent Customer Notification letters dated August 8, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact Zoll Technical Support Line at 1 (800) 348-9011 for further assistance.
- Quantity
- 3881 in US, 1846 ROW.
- Distribution
- Worldwide distribution.
- Lot, serial or model codes
- all
- 510(k) numbers
- ["K011046","K022345","K032852","K040453","K063602"]
- PMA numbers
- not on file
- Product code
- DRM
- Firm FEI
- 3003793491
- Firm city
- Sunnyvale
- Firm state
- CA
- 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