Recall Z-1904-2008
Physio Control, Inc. · initiated April 16, 2008
Product
Physio-Control LIFEPAK 12 defibrillator/monitor is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia.
Codes / lots: PL12 Part number: DVLP12-02-000023, DVLP12-02-000055, dvlp12-02-000100, DVLP12-02-000102, DVLP12-02-000170, DVLP12-02-000291, DVLP12-02-000450, dvlp12-02-000456, DVLP12-02-000476, DVLP12-02-000547, DVLP12-02-000615, DVLP12-02-000622, dvlp12-02-000629, DVLP12-02-000820, DVLP12-02-000827, DVLP12-02-000872, DVLP12-02-000880, DVLP12-02-001007, DVLP12-02-001008, DVLP12-02-001009, DVLP12-02-001042, DVLP12-02-001150, DVLP12-02-001152, DVLP12-02-001357, DVLP12-02-001361, dvlp12-02-001370, DVLP12-02-001384, DVLP12-02-001385, DVLP12-02-001396, DVLP12-02-001420, DVLP12-02-001433, DVLP12-02-001452, dvlp12-02-001485, DVLP12-02-002006, DVLP12-02-002139, DVLP12-02-002164, DVLP12-02-002174, DVLP12-02-002191, DVLP12-02-002230, dvlp12-02-002266, DVLP12-02-002277, dvlp12-02-002279, DVLP12-02-002280, DVLP12-02-002336, dvlp12-02-002509, DVLP12-02-002945, dvlp12-02-003473, DVLP12-02-003487, DVLP12-02-003787, UVLP12-02-000022, UVLP12-02-000023, UVLP12-02-000055, uvlp12-02-000066, UVLP12-02-000073, UVLP12-02-000099, UVLP12-02-000107, UVLP12-02-000110, UVLP12-02-000170, UVLP12-02-000172, UVLP12-02-000291, UVLP12-02-000295, UVLP12-02-000398, UVLP12-02-000455, UVLP12-02-000476, uvlp12-02-000478…
Reason for recall
The LIFEPAK 12 defibrillator / monitors with software version 130 have an increase in likelihood for an incorrect Shock Advisory Algorithm (SAS) decision if the Auto Analyze setting in AED mode is On, leading to incorrectly render of shock or no shock decision. When Auto Analyze is set to On in AED mode the device initiates the SAS analysis immediately (no waiting period or warning prior to analys
FDA-determined cause: Software design
Action taken
On April 16, 2008, a letter was sent to the firms customers, via certified mail explaining the recall, giving product and software version information, request for customer to forward the notification to all sites and recommending the following: "Keep the defibrillator in service... Check the Auto Analyze Setup Option for each of your devices. If Auto Analyze is set to ON, change the setting to one of the other two choices: OFF or After First Shock... Follow the enclosed instructions to confirm or change the Auto Analyze Setup Option setting...If you update your defibrillator with new software, confirm the Auto Analyze Setup Option is set to OFF or After First Shock". Instructions for changing the auto analyze setup option for the LP 12 and LP20 were attached to the letter. There was no software issued in response to this action. Since LP20 customers may purchase a software program allowing them to update their defibrillator software, the letter recommends confirming Auto Analyze Setup Option is set to OFF or After First Shock if new software is installed . The default setting for the software update is Auto-Analyze ON. Contact Technical Support at 1-800-442-1142, option 5 - 6:00 a.m. to 4:00 p,m, (Pacific), Monday - Friday or visit www.Physio-Control-notices.com/sas if you have questions.
Details
- Recall number
- Z-1904-2008
- Initiated
- April 16, 2008
- Posted by FDA
- September 16, 2008
- Terminated
- March 29, 2011
- Product code
- LDD – Dc-Defibrillator, Low-Energy, (Including Paddles)
- Quantity
- 19,805 units
- Distribution
- Product distributed nationwide and includes: 2 distributors, 157 direct accounts, 2,069 hospitals, 51 Department of Defense accounts, 58 miscellaneous government accounts, 3,295 first responders, 43 international accounts. International accounts are located in the following countries: ARGENTINA, AUSTRALIA, BARBADOS, BOLIVIA, BRAZIL, CANADA, CAYMAN ISLANDS, CHILE, COSTA RICA, DOMINICAN REPUBLIC…
- Recalling firm
- Physio Control, Inc., Redmond, WA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1905-2008 | Physio-Control LIFEPAK 20 defibrillator/monitor is indicated for the termination of…The LIFEPAK 20 defibrillator / monitors with software versions 048, 052 and 054 have an increase in… | 04/16/2008Terminated |
| Z-1906-2008 | Physio-Control LIFEPAK 20e defibrillator/monitor, sold internationally only, is…The LIFEPAK 20e defibrillator / monitors with software versions 058 have an increase in likelihood for an… | 04/16/2008Terminated |