Recall record at a glance
| Official record | Z-1144-2017 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Physio-Control, Inc. |
| Report date | Feb 15, 2017 |
| Recall initiation date | Jan 16, 2017 |
| Quantity | 2584 units total (1501 units in the US; 1034 units international; and 49 units owned by Physio). 50 modules total |
| Location | Redmond, WA, United States |
Official product description
LIFEPAK 15 Monitor/Defibrillator with End-Tidal CO2 option. Intended for use by trained medical personnel in out-of-doors and indoor emergency care settings within the environmental conditions specified in the Operating Instructions.
Why the product was recalled
The End-Tidal CO2 (EtCO2) reading can intermittently show a value of XXX after start-up or during device operation.
Distribution information
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.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
FDA source limitation: openFDA enforcement reports are a reference dataset, not a live public-alert or recall-lifecycle service. FDA notes that enforcement-report status may not be updated after classification. Confirm current actions with the FDA, recalling firm or appropriate healthcare professional when relevant.