Z-1143-2017 Class II Terminated
FDA device recall Z-1143-2017 was initiated by Physio-Control, Inc. on January 16, 2017 and is designated Class II. Reason for recall: The End-Tidal CO2 (EtCO2) reading can intermittently show a value of XXX after start-up or during device operation. The recall status is terminated (terminated September 11, 2018). Affected quantity: 7 units in the US and 13 modules worldwide (5 international; and 8 owned by Physio).
Recall Details
- Product Type
- Devices
- Report Date
- February 15, 2017
- Initiation Date
- January 16, 2017
- Termination Date
- September 11, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7 units in the US and 13 modules worldwide (5 international; and 8 owned by Physio)
Product Description
Reason for Recall
Distribution Pattern
Worldwide distribution. LifePak 12 distributed in US states of AL, GA, NY, SC, and in Australia. LifePak 15 distributed nationwide in the US including Puerto Rico and to ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, CANADA, CHILE, CZECH REPUBLIC, DENMARK, FINLAND, FRANCE, FRENCH GUIANA, GERMANY, GREECE, HUNGARY, ICELAND, IRELAND, ITALY, LITHUANIA, LUXEMBOURG, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, PORTUGAL, SAUDI ARABIA, SENEGAL, SERBIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWITZERLAND, TAHITI, UNITED ARAB EMIRATES, AND UNITED KINGDOM.