Recall Z-1143-2017
Physio-Control, Inc. · initiated January 16, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
LIFEPAK 12 Defibrillator/Monitor with End-Tidal CO2 option. The device is used in various areas of the hospital such as critical areas (emergency departments, critical care, operating room, etc.) and general duty floors (e.g. medical/surgical). The device is also used for in and out of hospital transport (air and ground ambulance, in hospital transport, etc.)
Codes / lots: LOT NUMBERS OF AFFECTED MODULE: Lot # 1520 and 1544. SERIAL NUMBERS OF DEVICES: 32877820, 34356891, 35984435, 37223110, 37440401, 37456675, and 37913307.
Reason for recall
The End-Tidal CO2 (EtCO2) reading can intermittently show a value of XXX after start-up or during device operation.
FDA-determined cause: Process control
Action taken
Physio Control sent the Urgent Medical Device Correction LIFEPAK 15 Monitor/ Defibrillator and LIFEPAK 12 Defibrillator/Monitor with End-Tidal CO2 (EtCO2) option letter, dated January 2017, and confirmation sheets to consignees on January 16, 2017. Physio-Control is contacting customers with affected devices to schedule the correction of their device(s), which will include replacing the EtCO2 module. Required Customer Actions: 1. Please forward this information to all affected sites, trainers and users that may have affected LIFEPAK 12 or LIFEPAK 15 device(s). 2. Consignees should follow the instructions on the Confirmation Sheet for each serial number listed in their possession. Promptly return the completed Confirmation Sheet to Physio-Control. 3. If consignees experience the XXX after power-up or during device operation, please contact Physio-Control to arrange for servicing of their device. Consignees should return completed confirmation sheet: -By fax to: 1-866-448-9567 -By email to: rsrecall@physio-control.com -Or by mail to: Physio-Control, Inc. P.O. Box 97006, Dept. 15N Redmond, WA, 98073-9706 Consignees with questions can call the firm at 1-800-442-1142, option 7, 6:00 A.M. to 4:00 P.M. (Pacific), Monday Friday.
Details
- Recall number
- Z-1143-2017
- Initiated
- January 16, 2017
- Terminated
- September 11, 2018
- Product code
- MKJ – Automated External Defibrillators (Non-Wearable)
- Quantity
- 7 units in the US and 13 modules worldwide (5 international; and 8 owned by Physio)
- Distribution
- 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…
- Recalling firm
- Physio-Control, Inc., Redmond, WA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1144-2017 Class II | LIFEPAK 15 Monitor/Defibrillator with End-Tidal CO2 option. Intended for use by trained…The End-Tidal CO2 (EtCO2) reading can intermittently show a value of XXX after start-up or during device… | 01/16/2017Terminated |