Enforcement Report - Week of October 10, 2012
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Product Detail
| Product Description | Philips HeartStart XL M4735A Defibrillator/Monitors, used with the M3516A batteries The Heart Start XL Defibrillator/Monitor is a fully featured, defibrillator intended for use by qualified medical personnel, trained in either Advanced Cardiac Life Support or in the operation of the device, in a hospital environment. |
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| Recall Number | Z-0011-2013 |
| Classification | Class II |
| Code Info | HeartStart XL battery M3516A labeled with Made in Taiwan and an R-2011-12 Date of Manufacture |
| Product Distributed Qty | 2500 units |
| Reason For Recall | HeartStart XL Defibrillator/Monitor (M4735A) used on a patient when AC power is not in use, with a battery that may fail, the device may shut down unexpectedly without providing the user with a low battery warning message or audible tone. |
Event Detail
| Event Id | 63116 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Philips Healthcare Inc. |
| City | Andover |
| State | MA | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-09-11 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Worldwide distribution: USA (Nationwide) and countries of: AUSTRALIA, BANGLADESH, BELGIUM, BRAZIL, CANADA, CHINA, COLOMBIA, CYPRUS, CZECH REPUBLIC, FINLAND, FRANCE, GERMANY HONG KONG, HUNGARY, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY JAPAN, JORDAN, KAZAKHSTAN, KENYA, KOREA, REPUBLIC OF KUWAIT LEBANON, MACAU, MALAYSIA, MEXICO, NAMIBIA, NETHERLANDS, NORWAY, OMAN, PERU, PHILIPPINES, POLAND, PORTUGAL, ROMANIA RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, PROVINCE OF CHINA, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, and VIET NAM. |
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