Severity
Moderate
FDA Devices recall · Reported December 21, 2016
Customer complaint was received relating to a LifePak15 device that would power on then power down unexpectedly after a short period of use. When the LP15 powered down, power cou…
Physio-Control, Inc. recalled The LIFEPAK 15 monitor/defibrillator is intended for use by trained medical personnel in… - a moderate-severity action.
The LIFEPAK 15 monitor/defibrillator is intended for use by trained medical personnel in… was recalled by Physio-Control, Inc. in December 21, 2016. Reason: Customer complaint was received relating to a LifePak15 device that would power on then power down unexpected…. Check the official notice for the remedy. Verify recall #Z-0761-2017 with the FDA Devices before acting.
The recall
Physio-Control, Inc. issued this moderate-severity FDA Devices recall-Customer complaint was received relating to a LifePak15 device that would power on then power down unexpected….
Sourced from official FDA Devices enforcement records. Verify recall #Z-0761-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-0761-2017) was formally reported on December 21, 2016, with the manufacturer initiating the action on March 11, 2010. 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 1399 units (866 in the US and 533 outside US).
The documented reason for this recall is: Customer complaint was received relating to a LifePak15 device that would power on then power down unexpectedly after a short period of use. When the LP15 powered down, power could be immediately restored by activation… Distribution data in the federal record shows the product reached: worldwide. 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.
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.
Severity
Moderate
Affected scope
1399 units (866 in the US and 533 outside US)
Related Recalls
6
3 from same agency
The LIFEPAK 15 monitor/defibrillator is intended for use by trained medical personnel in outdoor and indoor emergency care settings within the environmental conditions specified. Product Part Numbers V-15-2-000XXX
Customer complaint was received relating to a LifePak15 device that would power on then power down unexpectedly after a short period of use. When the LP15 powered down, power could be immediately restored by activation of the power button. The device was connected to a cellular modem from MultiTech systems for use with LIFE NET services. The corrective action was completed by Velocitor Solutions in December 2010.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0761-2017 |
| Date reported | December 21, 2016 |
| Date initiated | March 11, 2010 |
| Recalling firm | Physio-Control, Inc. |
| Firm location | Redmond, WA |
| Affected scope | 1399 units (866 in the US and 533 outside US) |
| Distribution | worldwide |
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.
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.
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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 December 21, 2016. 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.