Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported October 24, 2018
Philips HeartStart FR3 Defibrillator, Model: 861388, 861389 Product Usage: The HeartStart FR3 is used to treat suspected victims of ventricular fibrillation (VF), the most common cause of sudden cardiac arrest (SCA), and certain ventricular tachycardia (VTs). Both models are used with disposable pads applied to potential victims of SCA with the following symptoms: 1) Unresponsiveness 2) Absence of normal breathing The HeartStart FR3 is intended for adults and children over 55 pounds (25kg) o
Automated external defibrillators may not fully meet IPx5 water ingress specification. The device may fail to function should water intrusion occur.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Philips Electronics North America Corp. recalled Philips HeartStart FR3 Defibrillator, Model: 861388, 861389 Product Usage: The HeartS… - a moderate-severity action.
Philips HeartStart FR3 Defibrillator, Model: 861388, 861389 Product Usage: The HeartS… was recalled by Philips Electronics North America Corp. in October 24, 2018. Reason: Automated external defibrillators may not fully meet IPx5 water ingress specification. The device may fail to…. Check the official notice for the remedy. Verify recall #Z-0175-2019 with the FDA Devices before acting.
The recall
Philips Electronics North America Corp. issued this moderate-severity FDA Devices recall-Automated external defibrillators may not fully meet IPx5 water ingress specification. The device may fail to….
- Moderate
- severity level
- 432 units
- affected scope
- Class II
- classification
- October 24, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0175-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0175-2019) was formally reported on October 24, 2018, with the manufacturer initiating the action on October 10, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Philips Electronics North America Corp. is listed as the recalling firm, operating out of Bothell, WA. Federal records list the affected scope as 432.
The documented reason for this recall is: Automated external defibrillators may not fully meet IPx5 water ingress specification. The device may fail to function should water intrusion occur. Distribution data in the federal record shows the product reached: Worldwide Distribution - U.S Nationwide in the states of: GA, MO, IN, FL, NY, HI, CA, LA, WA, IL, NE; Foreign (OUS):Australia, Austria,Belgium, Canada, France, Germany, Hong Kong, Italy, Japan, Kazakhstan, Netherlan…. 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 - 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 - 40,422 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
432
Related Recalls
6
0 from same agency
Product description
Philips HeartStart FR3 Defibrillator, Model: 861388, 861389 Product Usage: The HeartStart FR3 is used to treat suspected victims of ventricular fibrillation (VF), the most common cause of sudden cardiac arrest (SCA), and certain ventricular tachycardia (VTs). Both models are used with disposable pads applied to potential victims of SCA with the following symptoms: 1) Unresponsiveness 2) Absence of normal breathing The HeartStart FR3 is intended for adults and children over 55 pounds (25kg) or 8 years old. Both models 861388 and 861389 are also intended for children under 55 pounds (25kg) or 8 years old when used with the optional Infant/Child Key. If the Infant/Child Key is not available, or you are uncertain of the child s age or weight, do not delay treatment. Device not sterile and not implantable.
Reason for recall
Automated external defibrillators may not fully meet IPx5 water ingress specification. The device may fail to function should water intrusion occur.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0175-2019 |
| Date reported | October 24, 2018 |
| Date initiated | October 10, 2018 |
| Recalling firm | Philips Electronics North America Corp. |
| Firm location | Bothell, WA |
| Affected scope | 432 |
| Distribution | Worldwide Distribution - U.S Nationwide in the states of: GA, MO, IN, FL, NY, HI, CA, LA, WA, IL, NE; Foreign (OUS):Australia, Austria,Belgium, Canada, France, Germany, Hong Kong, Italy, Japan, Kazakhstan, Netherlands, Norway, Spain, S… |
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-0175-2019) 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? ▼
Philips HeartStart FR3 Defibrillator, Model: 861388, 861389 Product Usage: The HeartStart FR3 is used to treat suspected victims of ventricular fibrillation (VF), the most common cause of sudden cardiac arrest (SCA), and certain ventricular tachycardia (VTs). Both models are used with disposable pads applied to potential victims of SCA with the following symptoms: 1) Unresponsiveness 2) Absence of normal breathing The HeartStart FR3 is intended for adults and children over 55 pounds (25kg) or 8 years old. Both models 861388 and 861389 are also intended for children under 55 pounds (25kg) or 8 years old when used with the optional Infant/Child Key. If the Infant/Child Key is not available, or you are uncertain of the child s age or weight, do not delay treatment. Device not sterile and not implantable.. Recalled by Philips Electronics North America Corp.. Units affected: 432.
Why was this product recalled? ▼
Automated external defibrillators may not fully meet IPx5 water ingress specification. The device may fail to function should water intrusion occur.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 24, 2018. Severity: Moderate. Recall number: Z-0175-2019.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - U.S Nationwide in the states of: GA, MO, IN, FL, NY, HI, CA, LA, WA, IL, NE; Foreign (OUS):Australia, Austria,Belgium, Canada, France, Germany, Hong Kong, Italy, Japan, Kazakhstan, Netherlands, Norway, Spain, Switzerland, Taiwan, United Kingdom.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0175-2019) 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 October 24, 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.