Zoll Auto Pulse Resuscitation System…

Date posted by the FDA

April 7, 2011

Status

Terminated

Filed by

Zoll Circulation, Inc.

Product

Zoll Auto Pulse Resuscitation System; Zoll Circulation Inc., Sunnyvale, CA 94085 Cardiac Compressor used as an adjunct to manual CPR. Use of AutoPulse is intended to reduce the impact of rescuer fatigue and enable rescuer to address other patient needs.

Reason

Complaints of batteries discharging prematurely and that during use the Auto Pulse Units would cease operating (providing compressions).

Distribution pattern

Nationwide Distribution -- including, VA, NY, OH, IN, MO, UT, FL, NC, ME, WA, SD, NM, PA, MS, ID, TX, GA, CA, CO, IL, AR, WV, TN, OR, and KS.

Quantity

not provided

Codes and lots

Model 100; AutoPulse product number 8700-0700-xx AutoPulse 1.5G; AutoPulse Battery Part Number 8799-0702-xx

Recall started

Jan. 28, 2008

Device type

Compressor, Cardiac, External

Root cause (FDA)

Other

What the company told customers

The firm, Zoll Circulation Inc., initiated a Corrective and Preventive Action Report on January 28, 2009. According to the firm, the customers were contacted by telephone calls and were provided with a Battery Maintenance program. For further questions you may call (408) 541-2140 ext.341.

Recall number

Z-1904-2011

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

Source: FDA · Medical device enforcement report, recall number Z-1904-2011. The agency record governs; check it and the company before acting.