FDA Device recall Z-0658-2013
AutoPulse Resuscitation System Model 100, Mfg by:Zoll Circulation Sunnyvale, CA. The AutoPulse Model 100 Automatic Mechanical Chest compres…
- FDA Device
- Class II
- terminated
- Published 2013-01-16
On 2013-01-16 the FDA classified a Class II recall of AutoPulse Resuscitation System Model 100, Mfg by:Zoll Circulation Sunnyvale, CA. The AutoPulse Model 100 Automatic Mechanical Chest compres… by Zoll Circulation, citing complaints associated with an unexpected stop in AutoPulse compressions.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0658-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-08-08 |
| Published | 2013-01-16 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Zoll Circulation |
| Distribution | n/a |
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.
Reason
Complaints associated with an unexpected stop in AutoPulse compressions.
Identifiers
| code_info | all |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0658-2013%22
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