Z-0658-2013Class II

AutoPulse Resuscitation System Model 100, Mfg by:Zoll Circulation Sunnyvale, CA. The AutoPulse Model 100...

Name: Z-0658-2013 AutoPulse Resuscitation System Model 100, Mfg by:Zoll Circulation Sunnyvale, CA. The AutoPulse Model 100...
Creator: Zoll Circulation, Inc.
Published: 2012-08-08
License: https://open.fda.gov/license/

ZOLL Circulation, Inc. / initiated 2012-08-08 / Terminated / root cause: manufacturing process

FDA source

Zoll Circulation, Inc. began a recall of AutoPulse Resuscitation System Model 100, Mfg by:Zoll Circulation Sunnyvale, CA. The AutoPulse Model 100 Automatic Mechanical Chest compressor is intended to... on 2012-08-08. FDA classified it as Class II and gives the reason as "Complaints associated with an unexpected stop in AutoPulse compressions". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0658-2013
Classification: Class II
Status: Terminated
Initiated: 2012-08-08
Posted: 2013-01-09
Terminated: 2014-05-12
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.
Product code: DRM Compressor, Cardiac, External
Reason for recall: Complaints associated with an unexpected stop in AutoPulse compressions.
Root cause tag: manufacturing process
FDA 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 in commerce: 3881 in US, 1846 ROW.
Distribution: Worldwide distribution.
Product codes and lots: all

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0658-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0658-2013	Class II	Terminated	Voluntary: Firm initiated	2013-01-16	2013-01-09

Product code DRM

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)