Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported February 14, 2018
MRx Defibrillator Model # M3535A & M3536A, UDI 00884838000018(21)US00601969 Product Usage: The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician
Affected units may have a defective component that is intended to protect the internal circuitry from high voltages during shock delivery. The defective component may also preven…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Philips North America, LLC recalled MRx Defibrillator Model # M3535A & M3536A, UDI 00884838000018(21)US00601969 Product Us… - a critical-severity action.
MRx Defibrillator Model # M3535A & M3536A, UDI 00884838000018(21)US00601969 Product Us… was recalled by Philips North America, LLC in February 14, 2018. Reason: Affected units may have a defective component that is intended to protect the internal circuitry from high vo…. Check the official notice for the remedy. Verify recall #Z-0489-2018 with the FDA Devices before acting.
The recall
Philips North America, LLC issued this critical-severity FDA Devices recall-Affected units may have a defective component that is intended to protect the internal circuitry from high vo….
- Critical
- severity level
- 71 units
- affected scope
- Class I
- classification
- February 14, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0489-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0489-2018) was formally reported on February 14, 2018, with the manufacturer initiating the action on July 12, 2017. It is classified under Critical severity (Class I), with a current status of Terminated. Philips North America, LLC is listed as the recalling firm, operating out of Andover, MA. Federal records list the affected scope as 71 units.
The documented reason for this recall is: Affected units may have a defective component that is intended to protect the internal circuitry from high voltages during shock delivery. The defective component may also prevent delivery of shocks in AED mode. Distribution data in the federal record shows the product reached: No U.S. distribution, Internationally to: India, Ireland, Japan, Republic of Korea, Malaysia, Mexico, South Africa & United Kingdom. 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
71 units
Related Recalls
6
3 from same agency
Product description
MRx Defibrillator Model # M3535A & M3536A, UDI 00884838000018(21)US00601969 Product Usage: The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician
Reason for recall
Affected units may have a defective component that is intended to protect the internal circuitry from high voltages during shock delivery. The defective component may also prevent delivery of shocks in AED mode.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-0489-2018 |
| Date reported | February 14, 2018 |
| Date initiated | July 12, 2017 |
| Recalling firm | Philips North America, LLC |
| Firm location | Andover, MA |
| Affected scope | 71 units |
| Distribution | No U.S. distribution, Internationally to: India, Ireland, Japan, Republic of Korea, Malaysia, Mexico, South Africa & United Kingdom |
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-0489-2018) 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? ▼
MRx Defibrillator Model # M3535A & M3536A, UDI 00884838000018(21)US00601969 Product Usage: The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician. Recalled by Philips North America, LLC. Units affected: 71 units.
Why was this product recalled? ▼
Affected units may have a defective component that is intended to protect the internal circuitry from high voltages during shock delivery. The defective component may also prevent delivery of shocks in AED mode.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 14, 2018. Severity: Critical. Recall number: Z-0489-2018.
Where was the recalled product distributed? ▼
Distribution: No U.S. distribution, Internationally to: India, Ireland, Japan, Republic of Korea, Malaysia, Mexico, South Africa & United Kingdom.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0489-2018) 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 February 14, 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.