Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported November 11, 2015
Philips HeartStart MRx Monitor/Defibrillators Models: M3535A and M3536A
1. Device will perform the weekly automated tests hourly, which could cause the therapy capacitors to degrade sooner than intended and 2. While connected to AC or DC power and wit…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Philips Medical Systems, Inc. recalled Philips HeartStart MRx Monitor/Defibrillators Models: M3535A and M3536A - a moderate-severity action.
Philips HeartStart MRx Monitor/Defibrillators Models: M3535A and M3536A was recalled by Philips Medical Systems, Inc. in November 11, 2015. Reason: 1. Device will perform the weekly automated tests hourly, which could cause the therapy capacitors to degrade…. Check the official notice for the remedy. Verify recall #Z-0204-2016 with the FDA Devices before acting.
The recall
Philips Medical Systems, Inc. issued this moderate-severity FDA Devices recall-1. Device will perform the weekly automated tests hourly, which could cause the therapy capacitors to degrade….
- Moderate
- severity level
- 2K units
- affected scope
- Class II
- classification
- November 11, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0204-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0204-2016) was formally reported on November 11, 2015, with the manufacturer initiating the action on November 19, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Philips Medical Systems, Inc. is listed as the recalling firm, operating out of Andover, MA. Federal records list the affected scope as 1553 units.
The documented reason for this recall is: 1. Device will perform the weekly automated tests hourly, which could cause the therapy capacitors to degrade sooner than intended and 2. While connected to AC or DC power and with no battery installed or the battery in… Distribution data in the federal record shows the product reached: Worldwide Distribution - USA (nationwide), Australia, Austria, Bahrain, Belgium, Brunei Darussalam, Canada, China, Finland, France, Germany, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Republic of Korea,…. 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
1553 units
Related Recalls
6
3 from same agency
Product description
Philips HeartStart MRx Monitor/Defibrillators Models: M3535A and M3536A
Reason for recall
1. Device will perform the weekly automated tests hourly, which could cause the therapy capacitors to degrade sooner than intended and 2. While connected to AC or DC power and with no battery installed or the battery installed has a charge level of less than 10%, the Ready for Use (RFU) indicator will not provide the expected low battery indication
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0204-2016 |
| Date reported | November 11, 2015 |
| Date initiated | November 19, 2014 |
| Recalling firm | Philips Medical Systems, Inc. |
| Firm location | Andover, MA |
| Affected scope | 1553 units |
| Distribution | Worldwide Distribution - USA (nationwide), Australia, Austria, Bahrain, Belgium, Brunei Darussalam, Canada, China, Finland, France, Germany, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Republic of Korea, Libyan Arab Jamahir… |
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-0204-2016) 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 MRx Monitor/Defibrillators Models: M3535A and M3536A. Recalled by Philips Medical Systems, Inc.. Units affected: 1553 units.
Why was this product recalled? ▼
1. Device will perform the weekly automated tests hourly, which could cause the therapy capacitors to degrade sooner than intended and 2. While connected to AC or DC power and with no battery installed or the battery installed has a charge level of less than 10%, the Ready for Use (RFU) indicator will not provide the expected low battery indication
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 11, 2015. Severity: Moderate. Recall number: Z-0204-2016.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - USA (nationwide), Australia, Austria, Bahrain, Belgium, Brunei Darussalam, Canada, China, Finland, France, Germany, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Republic of Korea, Libyan Arab Jamahiriya, Lithuania, Mexico, Namibia, Netherlands, Palestine, Philippines, Poland, Portugal, Qatar, Russian Federation, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Taiwan, United Arab Emirates and United Kingdom..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0204-2016) 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 November 11, 2015. 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.