Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported July 10, 2019
ZOLL AED PRO Automated External Defibrillator Product Usage: The AED PRO unit is intended to defibrillate victims of ventricular fibrillation or pulseless ventricular tachycardia, for ECG monitoring, and for CPR monitoring of patients. The CPR monitoring function provides a metronome designed to encourage rescuers to perform chest compressions at the AHA/ERC recommended rate of 100 compressions per minute. Voice and visual prompts encourage a compression depth of at least 2 inches (5 cm) for
There is a potential for the device to fail to deliver energy to the patient.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Zoll Medical Corporation recalled ZOLL AED PRO Automated External Defibrillator Product Usage: The AED PRO unit is inte… - a moderate-severity action.
ZOLL AED PRO Automated External Defibrillator Product Usage: The AED PRO unit is inte… was recalled by Zoll Medical Corporation in July 10, 2019. Reason: There is a potential for the device to fail to deliver energy to the patient.. Check the official notice for the remedy. Verify recall #Z-1931-2019 with the FDA Devices before acting.
The recall
Zoll Medical Corporation issued this moderate-severity FDA Devices recall-There is a potential for the device to fail to deliver energy to the patient..
- Moderate
- severity level
- 2K units
- affected scope
- Class II
- classification
- July 10, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1931-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1931-2019) was formally reported on July 10, 2019, with the manufacturer initiating the action on June 12, 2019. It is classified under Moderate severity (Class II), with a current status of Ongoing. Zoll Medical Corporation is listed as the recalling firm, operating out of Chelmsford, MA. Federal records list the affected scope as 1,969.
The documented reason for this recall is: There is a potential for the device to fail to deliver energy to the patient. Distribution data in the federal record shows the product reached: Worldwide Distribution - US nationwide. The products were distributed to the following foreign countries: Austria, Australia, Bangladesh, Brazil, Canada, China, Denmark, France, Germany, Great Britain, Indonesia, It…. 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
1,969
Related Recalls
6
3 from same agency
Product description
ZOLL AED PRO Automated External Defibrillator Product Usage: The AED PRO unit is intended to defibrillate victims of ventricular fibrillation or pulseless ventricular tachycardia, for ECG monitoring, and for CPR monitoring of patients. The CPR monitoring function provides a metronome designed to encourage rescuers to perform chest compressions at the AHA/ERC recommended rate of 100 compressions per minute. Voice and visual prompts encourage a compression depth of at least 2 inches (5 cm) for adult patients. The AED PRO system is indicated for use on victims of cardiac arrest with apparent lack of circulation as indicated by: Unconsciousness Absence of breathing, and Absence of pulse and other signs of circulation. The device is also indicated for use when ECG monitoring is indicated to evaluate the patient s heart rate or ECG morphology. The AED PRO system is indicated for adult and pediatric patients.
Reason for recall
There is a potential for the device to fail to deliver energy to the patient.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1931-2019 |
| Date reported | July 10, 2019 |
| Date initiated | June 12, 2019 |
| Recalling firm | Zoll Medical Corporation |
| Firm location | Chelmsford, MA |
| Affected scope | 1,969 |
| Distribution | Worldwide Distribution - US nationwide. The products were distributed to the following foreign countries: Austria, Australia, Bangladesh, Brazil, Canada, China, Denmark, France, Germany, Great Britain, Indonesia, Italy, Japan, Luxembur… |
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-1931-2019) 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? ▼
ZOLL AED PRO Automated External Defibrillator Product Usage: The AED PRO unit is intended to defibrillate victims of ventricular fibrillation or pulseless ventricular tachycardia, for ECG monitoring, and for CPR monitoring of patients. The CPR monitoring function provides a metronome designed to encourage rescuers to perform chest compressions at the AHA/ERC recommended rate of 100 compressions per minute. Voice and visual prompts encourage a compression depth of at least 2 inches (5 cm) for adult patients. The AED PRO system is indicated for use on victims of cardiac arrest with apparent lack of circulation as indicated by: Unconsciousness Absence of breathing, and Absence of pulse and other signs of circulation. The device is also indicated for use when ECG monitoring is indicated to evaluate the patient s heart rate or ECG morphology. The AED PRO system is indicated for adult and pediatric patients.. Recalled by Zoll Medical Corporation. Units affected: 1,969.
Why was this product recalled? ▼
There is a potential for the device to fail to deliver energy to the patient.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 10, 2019. Severity: Moderate. Recall number: Z-1931-2019.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US nationwide. The products were distributed to the following foreign countries: Austria, Australia, Bangladesh, Brazil, Canada, China, Denmark, France, Germany, Great Britain, Indonesia, Italy, Japan, Luxemburg, New Zealand, Panama, Russia, Saudi Arabia, Singapore, Spain, Thailand, Taiwan..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1931-2019) 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 July 10, 2019. 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.