Class II — Philips Medical Systems, Inc.
| Recalling firm | Philips Medical Systems International BV |
|---|---|
| Registered facility | View this company's 54 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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 |
| Product | Philips HeartStart MRx Monitor/Defibrillators Models: M3535A and M3536A |
| Quantity | 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 Jamahiriya, Lithuania, Mexico, Namibia, Netherlands, Palestine, Philippines, Poland, Portugal, Qatar, Russian Federation, Saudi Arabia, South Africa, Spain, Sweden, Swi… |
| Initiated | 2014-11-19 |
| Classified | 2015-11-03 |
| Terminated | 2016-08-15 |
| Recall number | Z-0204-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Philips Medical Systems, Inc. (Z-0204-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/69712/
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