Recall Z-0658-2013— Zoll Circulation, Inc.
Class II · Terminated
Class II FDA medical device recall by Zoll Circulation, Inc., initiated 2012-08-08, terminated 2014-05-12. It names 5 FDA 510(k) clearances: K063602, K040453, K032852 and 2 more. 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..
- Recalling firm
- Zoll Circulation, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-08-08
- Terminated
- 2014-05-12
- Firm location
- Sunnyvale, CA, United States
510(k) clearances named in this recall
5 on FDA's record- K063602 — AUTOPULSE RESUSCITATION SYSTEM MODEL100
- K040453 — AUTOPULSE RESUSCITATION SYSTEM, MODEL 100
- K032852 — MODIFICATION TO: AUTOPULSE RESUSCITATION SYSTEM MODEL 100
- K022345 — AUTOPULSE RESUSCITATION SYSTEM
- K011046 — AUTOPULSE, MODEL 100
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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 for recall
Complaints associated with an unexpected stop in AutoPulse compressions.
Data sourced from openFDA. This site is unofficial and independent of the FDA.