Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported April 5, 2017
HeartStart MRx Monitor/Defibrillator, Model numbers: M3535A (M3535ATZ) M3536A (M3536ATZ), M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9
HeartStart MRx Monitor/Defibrillator may may exhibit abnormal behavior when operating using a single battery as the sole source of power may fail to deliver therapy or monitoring
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Philips North America, LLC recalled HeartStart MRx Monitor/Defibrillator, Model numbers: M3535A (M3535ATZ) M3536A (M3536ATZ)… - a critical-severity action.
HeartStart MRx Monitor/Defibrillator, Model numbers: M3535A (M3535ATZ) M3536A (M3536ATZ)… was recalled by Philips North America, LLC in April 5, 2017. Reason: HeartStart MRx Monitor/Defibrillator may may exhibit abnormal behavior when operating using a single battery…. Check the official notice for the remedy. Verify recall #Z-1417-2017 with the FDA Devices before acting.
The recall
Philips North America, LLC issued this critical-severity FDA Devices recall-HeartStart MRx Monitor/Defibrillator may may exhibit abnormal behavior when operating using a single battery….
- Critical
- severity level
- Class I
- classification
- April 5, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1417-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1417-2017) was formally reported on April 5, 2017, with the manufacturer initiating the action on February 24, 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 97,794 total ( 47,362 US and 50,429 OUS).
The documented reason for this recall is: HeartStart MRx Monitor/Defibrillator may may exhibit abnormal behavior when operating using a single battery as the sole source of power may fail to deliver therapy or monitoring Distribution data in the federal record shows the product reached: Worldwide Distribution-US (Nationwide) including PUERTO RICO and countries of: AFGHANISTAN, ALBANIA, ANGOLA, ARGENTINA, ARUBA, AUSTRALIA,AUSTRIA,AZERBAIJAN,BAHRAIN, BANGLADESH, BELGIUM, BOLIVIA,BOSNIA AND HERZEGOWINA, B…. 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
97,794 total ( 47,362 US and 50,429 OUS)
Related Recalls
6
3 from same agency
Product description
HeartStart MRx Monitor/Defibrillator, Model numbers: M3535A (M3535ATZ) M3536A (M3536ATZ), M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9
Reason for recall
HeartStart MRx Monitor/Defibrillator may may exhibit abnormal behavior when operating using a single battery as the sole source of power may fail to deliver therapy or monitoring
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-1417-2017 |
| Date reported | April 5, 2017 |
| Date initiated | February 24, 2017 |
| Recalling firm | Philips North America, LLC |
| Firm location | Andover, MA |
| Affected scope | 97,794 total ( 47,362 US and 50,429 OUS) |
| Distribution | Worldwide Distribution-US (Nationwide) including PUERTO RICO and countries of: AFGHANISTAN, ALBANIA, ANGOLA, ARGENTINA, ARUBA, AUSTRALIA,AUSTRIA,AZERBAIJAN,BAHRAIN, BANGLADESH, BELGIUM, BOLIVIA,BOSNIA AND HERZEGOWINA, BRAZIL,BRUNEI DARUSSA… |
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-1417-2017) 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? ▼
HeartStart MRx Monitor/Defibrillator, Model numbers: M3535A (M3535ATZ) M3536A (M3536ATZ), M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9. Recalled by Philips North America, LLC. Units affected: 97,794 total ( 47,362 US and 50,429 OUS).
Why was this product recalled? ▼
HeartStart MRx Monitor/Defibrillator may may exhibit abnormal behavior when operating using a single battery as the sole source of power may fail to deliver therapy or monitoring
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 5, 2017. Severity: Critical. Recall number: Z-1417-2017.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution-US (Nationwide) including PUERTO RICO and countries of: AFGHANISTAN, ALBANIA, ANGOLA, ARGENTINA, ARUBA, AUSTRALIA,AUSTRIA,AZERBAIJAN,BAHRAIN, BANGLADESH, BELGIUM, BOLIVIA,BOSNIA AND HERZEGOWINA, BRAZIL,BRUNEI DARUSSALAM, BULGARIA,CAMBODIA,CANADA,CHILE,CHINA,COLOMBIA,COSTA RICA, CROATIA (local name: Hrvatska),CYPRUS,CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC,ECUADOR,EGYPT,EL SALVADOR, ESTONIA, ETHIOPIA,FINLAND,FRANCE,GABON,GERMANY,GHANA,GREECE, GUADELOUPE, HONG KONG,HUNGARY,ICELAND,INDIA, INDONESIA,IRAN (ISLAMIC REPUBLIC OF),IRAQ,IRELAND,ISRAEL,ITALY,JAPAN, JORDAN, KAZAKHSTAN, KENYA,KOREA, REPUBLIC OF,KUWAIT,LAOS,LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA,LITHUANIA,LUXEMBOURG, MACAU, MACEDONIA,MALAYSIA,MALTA,MAURITIUS,MEXICO,MONGOLIA, MOROCCO, MOZAMBIQUE,MYANMAR (Burma), NAMIBIA, NEPAL, NETHERLANDS, NETHERLANDS ANTILLES,NEW CALEDONIA,NEW ZEALAND, NICARAGUA, NIGERIA, NORWAY, OMAN, PAKISTAN, PALESTINE, PANAMA,PAPUA NEW GUINEA, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL,QATAR,REUNION,ROMANIA,RUSSIAN FEDERATION,SAUDI ARABIA, SERBIA, SINGAPORE, SLOVENIA,SOUTH AFRICA,SPAIN,SRI LANKA, SWEDEN,SWITZERLAND,TAIWAN, PROVINCE OF CHINA,TANZANIA, UNITED REPUBLIC OF,THAILAND,TRINIDAD AND TOBAGO, TUNISIA, TURKEY, TURKMENISTAN,UGANDA,UKRAINE,UNITED ARAB EMIRATES,UNITED KINGDOM,UZBEKISTAN,VENEZUELA,VIET NAM,YEMEN..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1417-2017) 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 April 5, 2017. 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.