Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported February 15, 2017
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.
The End-Tidal CO2 (EtCO2) reading can intermittently show a value of XXX after start-up or during device operation.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Physio-Control, Inc. recalled LIFEPAK 15 Monitor/Defibrillator with End-Tidal CO2 option. Intended for use by tr… - a moderate-severity action.
LIFEPAK 15 Monitor/Defibrillator with End-Tidal CO2 option. Intended for use by tr… was recalled by Physio-Control, Inc. in February 15, 2017. Reason: The End-Tidal CO2 (EtCO2) reading can intermittently show a value of XXX after start-up or during device oper…. Check the official notice for the remedy. Verify recall #Z-1144-2017 with the FDA Devices before acting.
The recall
Physio-Control, Inc. issued this moderate-severity FDA Devices recall-The End-Tidal CO2 (EtCO2) reading can intermittently show a value of XXX after start-up or during device oper….
- Moderate
- severity level
- 3K units
- affected scope
- Class II
- classification
- February 15, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1144-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1144-2017) was formally reported on February 15, 2017, with the manufacturer initiating the action on January 16, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. Physio-Control, Inc. is listed as the recalling firm, operating out of Redmond, WA. Federal records list the affected scope as 2584 units total (1501 units in the US; 1034 units international; and 49 units owned by Physio). 50 modules total.
The documented reason for this recall is: The End-Tidal CO2 (EtCO2) reading can intermittently show a value of XXX after start-up or during device operation. Distribution data in the federal record shows the product reached: 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, BAHR…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
2584 units total (1501 units in the US; 1034 units international; and 49 units owned by Physio). 50 modules total
Related Recalls
6
3 from same agency
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.
Reason for recall
The End-Tidal CO2 (EtCO2) reading can intermittently show a value of XXX after start-up or during device operation.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1144-2017 |
| Date reported | February 15, 2017 |
| Date initiated | January 16, 2017 |
| Recalling firm | Physio-Control, Inc. |
| Firm location | Redmond, WA |
| Affected scope | 2584 units total (1501 units in the US; 1034 units international; and 49 units owned by Physio). 50 modules total |
| 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… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1144-2017) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Physio-Control, Inc.. Units affected: 2584 units total (1501 units in the US; 1034 units international; and 49 units owned by Physio). 50 modules total.
Why was this product recalled? ▼
The End-Tidal CO2 (EtCO2) reading can intermittently show a value of XXX after start-up or during device operation.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 15, 2017. Severity: Moderate. Recall number: Z-1144-2017.
Where was the recalled product distributed? ▼
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 ZEALAND, NORWAY, POLAND, PORTUGAL, SAUDI ARABIA, SENEGAL, SERBIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWITZERLAND, TAHITI, UNITED ARAB EMIRATES, AND UNITED KINGDOM..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1144-2017) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported February 15, 2017. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.