AutoPulse Resuscitation System Model 100…

Date

Jan. 16, 2013

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Terminated

Filed by

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.

Reason

Complaints associated with an unexpected stop in AutoPulse compressions.

Distribution pattern

Worldwide distribution.

Quantity

3881 in US, 1846 ROW.

Codes and lots

all

Recall started

Aug. 8, 2012

Device type

Compressor, Cardiac, External

Root cause (FDA)

Employee error

What the company told customers

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.

Recall number

Z-0658-2013

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-0658-2013. The agency record governs; check it and the company before acting.