Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported January 17, 2018
LIFEPAK 20e DEFIBRILLATOR/MONITOR, 3201273 Product Usage: The LIFEPAK 20e defibrillator/monitor is intended for use in the hospital, physician s office, and clinic setting by personnel who are authorized by a physician/medical director. It is intended for use on a crash cart as well as for portable emergency response throughout a hospital.
Physio-Control is aware that some devices have had power-related failures as customers prepared their device for initial deployment or during use within the first year of distribu…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Physio-Control, Inc. recalled LIFEPAK 20e DEFIBRILLATOR/MONITOR, 3201273 Product Usage: The LIFEPAK 20e defibrillat… - a critical-severity action.
LIFEPAK 20e DEFIBRILLATOR/MONITOR, 3201273 Product Usage: The LIFEPAK 20e defibrillat… was recalled by Physio-Control, Inc. in January 17, 2018. Reason: Physio-Control is aware that some devices have had power-related failures as customers prepared their device …. Check the official notice for the remedy. Verify recall #Z-0294-2018 with the FDA Devices before acting.
The recall
Physio-Control, Inc. issued this critical-severity FDA Devices recall-Physio-Control is aware that some devices have had power-related failures as customers prepared their device ….
- Critical
- severity level
- 4K units
- affected scope
- Class I
- classification
- January 17, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0294-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0294-2018) was formally reported on January 17, 2018, with the manufacturer initiating the action on December 4, 2017. It is classified under Critical severity (Class I), 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 3831 units.
The documented reason for this recall is: Physio-Control is aware that some devices have had power-related failures as customers prepared their device for initial deployment or during use within the first year of distribution. The symptoms of these failures may… Distribution data in the federal record shows the product reached: Worldwide Distribution. 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 high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
3831 units
Related Recalls
6
3 from same agency
Product description
LIFEPAK 20e DEFIBRILLATOR/MONITOR, 3201273 Product Usage: The LIFEPAK 20e defibrillator/monitor is intended for use in the hospital, physician s office, and clinic setting by personnel who are authorized by a physician/medical director. It is intended for use on a crash cart as well as for portable emergency response throughout a hospital.
Reason for recall
Physio-Control is aware that some devices have had power-related failures as customers prepared their device for initial deployment or during use within the first year of distribution. The symptoms of these failures may include unexpected power on and power off, device lock-up, or a failure to power on or off, any of which has the potential to result in a failure to deliver therapy to the patient and serious injury or death.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-0294-2018 |
| Date reported | January 17, 2018 |
| Date initiated | December 4, 2017 |
| Recalling firm | Physio-Control, Inc. |
| Firm location | Redmond, WA |
| Affected scope | 3831 units |
| Distribution | Worldwide Distribution |
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-0294-2018) 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.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. 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 20e DEFIBRILLATOR/MONITOR, 3201273 Product Usage: The LIFEPAK 20e defibrillator/monitor is intended for use in the hospital, physician s office, and clinic setting by personnel who are authorized by a physician/medical director. It is intended for use on a crash cart as well as for portable emergency response throughout a hospital.. Recalled by Physio-Control, Inc.. Units affected: 3831 units.
Why was this product recalled? ▼
Physio-Control is aware that some devices have had power-related failures as customers prepared their device for initial deployment or during use within the first year of distribution. The symptoms of these failures may include unexpected power on and power off, device lock-up, or a failure to power on or off, any of which has the potential to result in a failure to deliver therapy to the patient and serious injury or death.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 17, 2018. Severity: Critical. Recall number: Z-0294-2018.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0294-2018) 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 January 17, 2018. 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.